Amgen Job ID: R-92188 Location: Thousand Oaks, CA, US 91360 The Sr Engineer will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Amgen Thousand Oaks site. Responsibilities include: Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order. Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary. Monitor systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Up to 10% domestic/international travel Basic Qualifications Doctorate degree OR Master's degree and 3 years of Engineering experience OR Bachelor's degree and 5 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience Preferred Qualifications Master's degree in Chemical or Mechanical Engineering 6+ years' of relevant work experience with 3+ years' experience in Biopharmaceutical operations/manufacturing environment Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as automated device assembly lines, bottling fill line, device build presses, labeling equipment, inspection equipment, continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343595
Jan 24, 2020
Amgen Job ID: R-92188 Location: Thousand Oaks, CA, US 91360 The Sr Engineer will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Amgen Thousand Oaks site. Responsibilities include: Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order. Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary. Monitor systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Up to 10% domestic/international travel Basic Qualifications Doctorate degree OR Master's degree and 3 years of Engineering experience OR Bachelor's degree and 5 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience Preferred Qualifications Master's degree in Chemical or Mechanical Engineering 6+ years' of relevant work experience with 3+ years' experience in Biopharmaceutical operations/manufacturing environment Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as automated device assembly lines, bottling fill line, device build presses, labeling equipment, inspection equipment, continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343595
Amgen Job ID: R-92169 Location: Thousand Oaks, CA, US 91360 Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. Within Global Commercial Operations, we provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities. As part of a new group within Commercial Data and Analytics - Data Sciences the Data Scientist Sr. Associate will collaborate with business partners, service owners and IS peers to define and manage a capability and technology roadmap for delivering optimized user experience for data consumers across the US Commercial Organization. This role will innovate and create significant business impact through the strategic use of technology and information. This position will help create competitive advantages for Amgen with the ultimate aim to provide clean, usable data to whomever may require it. This position will be primarily responsible for: Ensuring rapid access to new and existing data assets Researching opportunities for data acquisition and new uses for existing data Overseeing end to end data integration and curation including building quality into the process Creating prototypes and demonstrations to better access and utilize data assets Employing a variety of languages and tools (e.g. scripting languages, big data tools) to marry systems together Collaborating cross-functionally with stakeholders to ensure a superb user experience throughout the data integration process Managing back-end data configuration Creating data models and solutions architecture in collaboration with IS and external partners Defining processes for managing access to data sets Triaging issues and working with external partners as needed Developing tools and training on data sets and access Collaborating to design, construct, install, test and maintain highly scalable data management systems Ensuring systems meet business requirements and industry best practices Collaborating on definition and implementation of disaster recovery procedures Recommending and implementing ways to improve data reliability, efficiency and quality Collaborating with data architects, modelers and IT team members on project goals Verbally presenting analysis ideas, progress and results to IS peers and business partners. Providing high quality ongoing support; answering questions, resolving problems and building solutions. Assuring compliance with regulatory, security, and privacy requirements as it relates to data assets Serving as an internal consultant on commercial data and data quality management Identifying, recommending and driving continuous improvement in database reporting and analysis processes Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Data Modeling/ Mining and Information Systems experience Preferred Qualifications: Master's Degree in Science, Engineering, Mathematics, Applied Physics, Statistics, or Operations Research 3+ years of relevant work experience Experience with databases Programming experience Detail-oriented technical aptitude with strong logical, problem solving, and decision-making skills. Excellent organization/planning skills and talent for managing many large and complex datasets. Ability to prototype data driven solutions to problems Ability to collaborate with business partners and other IS resources to drive analytic projects end-to-end. Ability to communicate analysis in a clear, precise, and actionable manner. Experience working with large data sets We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343633
Jan 24, 2020
Amgen Job ID: R-92169 Location: Thousand Oaks, CA, US 91360 Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. Within Global Commercial Operations, we provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities. As part of a new group within Commercial Data and Analytics - Data Sciences the Data Scientist Sr. Associate will collaborate with business partners, service owners and IS peers to define and manage a capability and technology roadmap for delivering optimized user experience for data consumers across the US Commercial Organization. This role will innovate and create significant business impact through the strategic use of technology and information. This position will help create competitive advantages for Amgen with the ultimate aim to provide clean, usable data to whomever may require it. This position will be primarily responsible for: Ensuring rapid access to new and existing data assets Researching opportunities for data acquisition and new uses for existing data Overseeing end to end data integration and curation including building quality into the process Creating prototypes and demonstrations to better access and utilize data assets Employing a variety of languages and tools (e.g. scripting languages, big data tools) to marry systems together Collaborating cross-functionally with stakeholders to ensure a superb user experience throughout the data integration process Managing back-end data configuration Creating data models and solutions architecture in collaboration with IS and external partners Defining processes for managing access to data sets Triaging issues and working with external partners as needed Developing tools and training on data sets and access Collaborating to design, construct, install, test and maintain highly scalable data management systems Ensuring systems meet business requirements and industry best practices Collaborating on definition and implementation of disaster recovery procedures Recommending and implementing ways to improve data reliability, efficiency and quality Collaborating with data architects, modelers and IT team members on project goals Verbally presenting analysis ideas, progress and results to IS peers and business partners. Providing high quality ongoing support; answering questions, resolving problems and building solutions. Assuring compliance with regulatory, security, and privacy requirements as it relates to data assets Serving as an internal consultant on commercial data and data quality management Identifying, recommending and driving continuous improvement in database reporting and analysis processes Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Data Modeling/ Mining and Information Systems experience Preferred Qualifications: Master's Degree in Science, Engineering, Mathematics, Applied Physics, Statistics, or Operations Research 3+ years of relevant work experience Experience with databases Programming experience Detail-oriented technical aptitude with strong logical, problem solving, and decision-making skills. Excellent organization/planning skills and talent for managing many large and complex datasets. Ability to prototype data driven solutions to problems Ability to collaborate with business partners and other IS resources to drive analytic projects end-to-end. Ability to communicate analysis in a clear, precise, and actionable manner. Experience working with large data sets We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343633
Amgen Job ID: R-91685 Location: Thousand Oaks, CA, US 91360 Amgen's 10 - 12 week internship program offers meaningful project experiences that impact patient's lives. This internship provides the opportunity for executive and social networking events and to participate in community volunteer projects while providing a competitive compensation. Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates. The Amgen Early Development group in Medical Sciences support the design and manage operational activities related to the planning, implementation, and reporting of results of phase 0-1 and 1b clinical trials in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer. The intern will be assigned to work with multiple clinical research study management teams and may engage in the following activities: Gain a general knowledge of GCP, ICH, and Amgen process in the conduct of Early Development clinical trials Contribute to team and study deliverables such as pharmacy manuals, informed consent forms, site training materials, and review of clinical trial data trends Participate in a longitudinal project that assesses or helps address a need for the department Conduct at least 1 lecture for clinical research staff in Early Development on pharmacy topics that impact our clinical trials Gain experience working in clinical trial management teams to better assess the direction of their career path. Basic Qualifications Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Graduated with a Bachelor's degree from an accredited college or university with a 3.0 minimum GPA or equivalent Completion as a first year graduate student before internship starts and currently enrolled in a PharmD program for a PharmD internship OR PhD for a PhD internship from an accredited college or university Enrolled in an accredited college or university following the potential internship or co-op assignment Must not be employed at the time the internship starts Preferred Qualifications Currently pursuing Doctor of Pharmacy degree and within third year or above of professional division studies Strong analytical skills, problem solving abilities, and the ability to think strategically Self-starter with high attention to detail, able to work independently Interpersonal skills as well as excellent verbal, written communication & presentation skills. Experience with Microsoft Excel, Web design and Sharepoint online Only candidates who apply via http://careers.amgen.com/ will be considered. Please search for Keyword 91685. #LI-DNP Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343658
Jan 24, 2020
Amgen Job ID: R-91685 Location: Thousand Oaks, CA, US 91360 Amgen's 10 - 12 week internship program offers meaningful project experiences that impact patient's lives. This internship provides the opportunity for executive and social networking events and to participate in community volunteer projects while providing a competitive compensation. Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates. The Amgen Early Development group in Medical Sciences support the design and manage operational activities related to the planning, implementation, and reporting of results of phase 0-1 and 1b clinical trials in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer. The intern will be assigned to work with multiple clinical research study management teams and may engage in the following activities: Gain a general knowledge of GCP, ICH, and Amgen process in the conduct of Early Development clinical trials Contribute to team and study deliverables such as pharmacy manuals, informed consent forms, site training materials, and review of clinical trial data trends Participate in a longitudinal project that assesses or helps address a need for the department Conduct at least 1 lecture for clinical research staff in Early Development on pharmacy topics that impact our clinical trials Gain experience working in clinical trial management teams to better assess the direction of their career path. Basic Qualifications Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Graduated with a Bachelor's degree from an accredited college or university with a 3.0 minimum GPA or equivalent Completion as a first year graduate student before internship starts and currently enrolled in a PharmD program for a PharmD internship OR PhD for a PhD internship from an accredited college or university Enrolled in an accredited college or university following the potential internship or co-op assignment Must not be employed at the time the internship starts Preferred Qualifications Currently pursuing Doctor of Pharmacy degree and within third year or above of professional division studies Strong analytical skills, problem solving abilities, and the ability to think strategically Self-starter with high attention to detail, able to work independently Interpersonal skills as well as excellent verbal, written communication & presentation skills. Experience with Microsoft Excel, Web design and Sharepoint online Only candidates who apply via http://careers.amgen.com/ will be considered. Please search for Keyword 91685. #LI-DNP Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343658
Amgen Job ID: R-91127 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Senior Associate - Business Systems Analyst (BSA) to work in our Ecosystem Rationalization team in the Office for the CIO (OCIO). The OCIO is focused on driving productivity and transformation throughout the IS organization. The Senior Associate BSA will be responsible for providing data analytics and financial systems support that help drive ecosystem rationalization efforts across the Information Services (IS) organization. Key Responsibilities of the Senior Associate - Business Systems Analyst will include: Engage with all functions and levels of IS to drive ecosystem rationalization including application decommissioning, removal of unnecessary technology environments, and infrastructure optimization Through agile delivery concepts, create new and innovative ways to analyze data related to technology and its spend developing action plans to drive future transformation Manage the operational activities of the Eco Rationalization team employing a lean factory mindset and showcasing progress to Executive Leadership Contribute to the definition of the next generation sustainable application decommissioning and other rationalization processes leveraging upgraded technology and automation Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Information Systems experience OR Associate's degree and 6 years of Information Systems experience OR High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications: Knowledge of application portfolio and finance systems such as ServiceNow, SAP and Arriba Contract Workspace Strong oral and presentation skills; ability to negotiate and persuade Strong project management skills and experience managing a large number of items through complex processes Knowledge of, and experience in, change management and supporting transformation tools and processes Ability to collaborate coordinate with functions and staff in the company and outside vendors to achieve communications and business objectives Ability to navigate a challenging and dynamic environment productively Ability to work on multiple projects simultaneously Ability to deal with rapidly changing priorities Ability to interact with all levels of management, staff and vendors Excellent interpersonal skills; enthusiastic, team player and self-starter; serious commitment to hard work and excellence Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343765
Jan 24, 2020
Amgen Job ID: R-91127 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Senior Associate - Business Systems Analyst (BSA) to work in our Ecosystem Rationalization team in the Office for the CIO (OCIO). The OCIO is focused on driving productivity and transformation throughout the IS organization. The Senior Associate BSA will be responsible for providing data analytics and financial systems support that help drive ecosystem rationalization efforts across the Information Services (IS) organization. Key Responsibilities of the Senior Associate - Business Systems Analyst will include: Engage with all functions and levels of IS to drive ecosystem rationalization including application decommissioning, removal of unnecessary technology environments, and infrastructure optimization Through agile delivery concepts, create new and innovative ways to analyze data related to technology and its spend developing action plans to drive future transformation Manage the operational activities of the Eco Rationalization team employing a lean factory mindset and showcasing progress to Executive Leadership Contribute to the definition of the next generation sustainable application decommissioning and other rationalization processes leveraging upgraded technology and automation Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Information Systems experience OR Associate's degree and 6 years of Information Systems experience OR High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications: Knowledge of application portfolio and finance systems such as ServiceNow, SAP and Arriba Contract Workspace Strong oral and presentation skills; ability to negotiate and persuade Strong project management skills and experience managing a large number of items through complex processes Knowledge of, and experience in, change management and supporting transformation tools and processes Ability to collaborate coordinate with functions and staff in the company and outside vendors to achieve communications and business objectives Ability to navigate a challenging and dynamic environment productively Ability to work on multiple projects simultaneously Ability to deal with rapidly changing priorities Ability to interact with all levels of management, staff and vendors Excellent interpersonal skills; enthusiastic, team player and self-starter; serious commitment to hard work and excellence Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343765
Amgen Job ID: R-90186 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Massachusetts - Cambridge The Senior Systems Engineer (SSE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The Senior Systems Engineer drives the architecture, vision and design requirements for the product while balancing implementation complexity, risk, manufacturability, serviceability and reliability. S/he understands and captures the user needs into system requirements and is responsible for the functional decomposition and allocation to subsystems. S/he ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. The Senior Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality. Responsibilities: Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones Conduct and review advanced computer simulations to design or test products Prepare cost estimates on proposed major design products Provide technical presentation support and consultation to marketing Represent company unit in customer or field force contacts Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs Produce innovative technical solutions to customers Prepare technical proposals for competitive bids Develop potential applications to exploit new business opportunities Collect and analyze information on competitor product performance Utilize project planning and monitoring methods to ensure timely completion Originate and communicate concepts which could lead to new products Review and approve completed design work Actively contributes to identifying and pursuing new technological opportunities Basic Qualifications Doctorate degree OR Master's degree and 3 years of Engineering and/or devicedevelopment/manufacturingexperience OR Bachelor's degree and 5 years of Engineering and/or devicedevelopment/manufacturingexperience OR Associate's degree and 10 years of Engineering and/or devicedevelopment/manufacturingexperience OR High School diploma/GED and 12 years of Engineering and/or devicedevelopment/manufacturingexperience Preferred Qualifications 10+ years of progressive experience as an engineer or scientist within the appropriate field of study 5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III INCOSE certification or formal Systems Engineering training/certification Demonstrated applied lean 6 Sigma competency Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.) Experience in model-based design and UML and Small scale device assembly experience Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance) Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis) Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc. Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position Familiar with the following standards: US Good Manufacturing Practices - 21CFR820 Quality Management - ISO 13485 Risk Management - ISO 14971 EU Medical Device requirements - Council Directive 93/42/EEC Medical Electrical Equipment - EN 60601 Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives Strong interpersonal skills The position is located in Thousand Oaks, CA and involves up to 10% domestic and international travel Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343799
Jan 24, 2020
Amgen Job ID: R-90186 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Massachusetts - Cambridge The Senior Systems Engineer (SSE) leads small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of an NPI program. The Senior Systems Engineer drives the architecture, vision and design requirements for the product while balancing implementation complexity, risk, manufacturability, serviceability and reliability. S/he understands and captures the user needs into system requirements and is responsible for the functional decomposition and allocation to subsystems. S/he ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program. The Senior Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality. Responsibilities: Analyze problems involving cross-disciplinary aspects of the product development process, synthesize multiple solutions. Develop and exploit structured, efficient approaches to analysis and design to solve complex engineering problems Provide direction and support for the optimal design of complex, large scale systems through consideration of the system as a whole, rather than individual components of the system Provide various client areas with accurate and consistent requirements information to help them make critical technical decisions based on complete and unambiguous insight into cross-systems functionality Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones Conduct and review advanced computer simulations to design or test products Prepare cost estimates on proposed major design products Provide technical presentation support and consultation to marketing Represent company unit in customer or field force contacts Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs Produce innovative technical solutions to customers Prepare technical proposals for competitive bids Develop potential applications to exploit new business opportunities Collect and analyze information on competitor product performance Utilize project planning and monitoring methods to ensure timely completion Originate and communicate concepts which could lead to new products Review and approve completed design work Actively contributes to identifying and pursuing new technological opportunities Basic Qualifications Doctorate degree OR Master's degree and 3 years of Engineering and/or devicedevelopment/manufacturingexperience OR Bachelor's degree and 5 years of Engineering and/or devicedevelopment/manufacturingexperience OR Associate's degree and 10 years of Engineering and/or devicedevelopment/manufacturingexperience OR High School diploma/GED and 12 years of Engineering and/or devicedevelopment/manufacturingexperience Preferred Qualifications 10+ years of progressive experience as an engineer or scientist within the appropriate field of study 5+ years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III INCOSE certification or formal Systems Engineering training/certification Demonstrated applied lean 6 Sigma competency Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components Demonstrated experience with NPI ISO and regulatory compliance process, design history file and collaterals are in place and current Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues Demonstrated skills in proactively identifying, facilitating and driving closure of a product/program Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.) Experience in model-based design and UML and Small scale device assembly experience Experience in system design and architecture that ensure product development success and ensuring Accurate Development Cycles between teams Leadership ability for System Level Design and Testing (Verification and Validation testing of System Level Performance) Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis) Experience in resolving system engineering issues such as device hardware/firmware or device/programmer system architecture design tradeoffs, tolerance/performance analysis, etc. Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position Familiar with the following standards: US Good Manufacturing Practices - 21CFR820 Quality Management - ISO 13485 Risk Management - ISO 14971 EU Medical Device requirements - Council Directive 93/42/EEC Medical Electrical Equipment - EN 60601 Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives Strong interpersonal skills The position is located in Thousand Oaks, CA and involves up to 10% domestic and international travel Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343799
Amgen Job ID: R-91186 Location: Thousand Oaks, CA, US 91360 The Sr. Manager, Manufacturing will manage the Chemicals Category and/or participate in multiple cross-functional initiatives for Chemical suppliers to ensure that raw materials do not negatively impact Amgen processes or patients. This role is responsible for managing both suppliers and cross-functional teams (Technical, Quality, Supply Chain and Sourcing) to ensure quality, supply, sourcing of raw materials, risk mitigation activities. This position is also responsible for managing and monitoring key performance measures that will ensure quality and supply to ensure high raw material performance for all Amgen Manufacturing Sites. SPECIFIC RESPONSIBILITIES: Position will be Category Lead for Chemicals Raw Materials and their suppliers. Will be responsible to work with key suppliers to improve quality and reliability by reducing variability in our operations utilizing Operational Excellence tools and principles Act as "Plant Manager" for his/her respective materials and suppliers, partnering with sites to drive initiatives to ensure quality, cost, and delivery of products are consistently met Develop sourcing strategies and supply chain to support Small Molecule business requirements Lead teams to manage supplier quality records closure adherence and ensure records are not aging Lead cross functional teams to mitigate any supply assurance issues to prevent manufacturing disruption Lead sourcing activities to identify, select, and onboard suppliers for new raw materials and alternate sources for risk mitigation Partner with cross-functional team and SRE partner to ensure objective/ goal alignment and adequate resourcing Partner with Suppliers and Amgen Manufacturing Plants to deliver year over year productivity initiatives and savings Leverages and utilizes Operational Excellence tools and resources to institutionalize continuous improvement mindset Understand impact of quality and application of raw materials across the Enterprise Work hand-in-hand with internal quality, supply chain and process development organizations to ensure supplier sites are monitored and corrective actions are implemented in a timely fashion Ensure quality records are resourced and adhering to closure date targets Work with Operations Risk Management to evaluate the supplier's Business continuity plans for alignment of expectations, the identification of gaps and improvement opportunities Increases supply chain transparency (N-X, VSM, etc.) Lead suppliers in developing advanced end-to-end supply chain processes to improve the management of inventory levels, risk mitigation, and supplier / Amgen efficiency Analyze, consolidate, and report demand and supply plans at the component / supplier level and provide supplier forecasts Analyze company raw material inventory plans including inventory levels, scrap, inventory purchases, category spend and consumption and determine areas for improvement Drive Continuous Improvement effort between supply chains (I.e. Lead time reduction, flexibility, supplier responsiveness, forecast accuracy, on time delivery, etc.) Facilitate Operational and Executive reviews Responsible for oversight of goals and Key Performance Indicators Domestic and International travel average up to 20% Basic Qualifications Doctorate degree and 2 years of Process Development or Small Molecule Manufacturing experience OR Master's degree and 6 years of Process Development or Small Molecule Manufacturing experience OR Bachelor's degree and 8 years of Process Development or Small Molecule Manufacturing experience OR Associate's degree and 10 years of Small Molecule Manufacturing experience OR High school diploma / GED and 12 years of Small Molecule Manufacturing experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources A bility to travel internationally and domestically up to 20% Preferred Qualifications Small Molecule Experience Technical Knowledge of Chemicals and how they are used in Amgen manufacturing processes Strong GMP knowledge and background Demonstrated ability to manage and lead cross-functional teams/ outside parties (suppliers / CMO's) 2 + years project leadership in a lead role (define, approve, develop milestones and metrics). MBA Knowledge and experience with Quality Management Systems Supplier negotiations and contract review experience Experience with advanced supply chain replenishment programs - Pull, JIT, VMI Strong ERP knowledge Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343818
Jan 24, 2020
Amgen Job ID: R-91186 Location: Thousand Oaks, CA, US 91360 The Sr. Manager, Manufacturing will manage the Chemicals Category and/or participate in multiple cross-functional initiatives for Chemical suppliers to ensure that raw materials do not negatively impact Amgen processes or patients. This role is responsible for managing both suppliers and cross-functional teams (Technical, Quality, Supply Chain and Sourcing) to ensure quality, supply, sourcing of raw materials, risk mitigation activities. This position is also responsible for managing and monitoring key performance measures that will ensure quality and supply to ensure high raw material performance for all Amgen Manufacturing Sites. SPECIFIC RESPONSIBILITIES: Position will be Category Lead for Chemicals Raw Materials and their suppliers. Will be responsible to work with key suppliers to improve quality and reliability by reducing variability in our operations utilizing Operational Excellence tools and principles Act as "Plant Manager" for his/her respective materials and suppliers, partnering with sites to drive initiatives to ensure quality, cost, and delivery of products are consistently met Develop sourcing strategies and supply chain to support Small Molecule business requirements Lead teams to manage supplier quality records closure adherence and ensure records are not aging Lead cross functional teams to mitigate any supply assurance issues to prevent manufacturing disruption Lead sourcing activities to identify, select, and onboard suppliers for new raw materials and alternate sources for risk mitigation Partner with cross-functional team and SRE partner to ensure objective/ goal alignment and adequate resourcing Partner with Suppliers and Amgen Manufacturing Plants to deliver year over year productivity initiatives and savings Leverages and utilizes Operational Excellence tools and resources to institutionalize continuous improvement mindset Understand impact of quality and application of raw materials across the Enterprise Work hand-in-hand with internal quality, supply chain and process development organizations to ensure supplier sites are monitored and corrective actions are implemented in a timely fashion Ensure quality records are resourced and adhering to closure date targets Work with Operations Risk Management to evaluate the supplier's Business continuity plans for alignment of expectations, the identification of gaps and improvement opportunities Increases supply chain transparency (N-X, VSM, etc.) Lead suppliers in developing advanced end-to-end supply chain processes to improve the management of inventory levels, risk mitigation, and supplier / Amgen efficiency Analyze, consolidate, and report demand and supply plans at the component / supplier level and provide supplier forecasts Analyze company raw material inventory plans including inventory levels, scrap, inventory purchases, category spend and consumption and determine areas for improvement Drive Continuous Improvement effort between supply chains (I.e. Lead time reduction, flexibility, supplier responsiveness, forecast accuracy, on time delivery, etc.) Facilitate Operational and Executive reviews Responsible for oversight of goals and Key Performance Indicators Domestic and International travel average up to 20% Basic Qualifications Doctorate degree and 2 years of Process Development or Small Molecule Manufacturing experience OR Master's degree and 6 years of Process Development or Small Molecule Manufacturing experience OR Bachelor's degree and 8 years of Process Development or Small Molecule Manufacturing experience OR Associate's degree and 10 years of Small Molecule Manufacturing experience OR High school diploma / GED and 12 years of Small Molecule Manufacturing experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources A bility to travel internationally and domestically up to 20% Preferred Qualifications Small Molecule Experience Technical Knowledge of Chemicals and how they are used in Amgen manufacturing processes Strong GMP knowledge and background Demonstrated ability to manage and lead cross-functional teams/ outside parties (suppliers / CMO's) 2 + years project leadership in a lead role (define, approve, develop milestones and metrics). MBA Knowledge and experience with Quality Management Systems Supplier negotiations and contract review experience Experience with advanced supply chain replenishment programs - Pull, JIT, VMI Strong ERP knowledge Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343818
Amgen Job ID: R-92158 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Compliance Director - US Healthcare to be based in our global headquarters in Thousand Oaks, CA. The Compliance Director will report to the Executive Director of Compliance. The Compliance Director will oversee the Compliance Program at a functional level. Most importantly, this individual will serve as the "face" of WC&BE to the business and will work objectively to provide strategic guidance on compliance issues or concerns within the function. Amgen's Worldwide Compliance and Business Ethics department (WC&BE) consists of a highly qualified and motivated team of professionals who identify, review, evaluate, manage and advise on compliance considerations within the organization. Responsibilities for the Compliance Director include: Advises business leadership in Global Commercial Operations and Corporate Affairs for portions of the US Business Manages day-to-day compliance related questions and issues Ensures policies and standards are understood and followed Ensures alignment and proper communication and training around systems and guidance Identifies potential areas of compliance vulnerability and risk Provides strategic guidance on compliance issues and situations Acts as the channel of communication for compliance related issues Provides training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts Remains abreast of external compliance activities Implements compliance engagement, or where appropriate, corrective action plans Special projects and other duties as assigned Works with other WC&BE teams including, Policy, Training, Communication & Anti-Corruption, Healthcare Compliance Operations, Audit & Monitoring, Investigations, and Regional Compliance Cross-functionally partners with Regulatory Promotions, Legal, Human Resources Domestic travel for this role may be up to 25% Basic Qualifications: Doctorate degree & 4 years of Regulatory and/or Legal and/or Compliance experience OR Master's degree & 7 years of Regulatory and/or Legal and/or Compliance experience OR Bachelor's degree & 9 years of Regulatory and/or Legal and/or Compliance experience Preferred Qualifications: Knowledge of related laws and regulations Understanding of sales, marketing, product promotion, disease education, device regulatory, clinical research and healthcare compliance Pharmaceutical / Biotech industry experience, particularly in Compliance, Legal, Regulatory Affairs, or cross-functional experience in Sales or Marketing, Medical Direct responsibility for counseling and influencing internal clients and cross functional stakeholders Ability to handle ambiguity and complex situations Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude Ability to think strategically and to translate strategy into action plans Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player Ability to work with all levels of management and build relationships across disciplines Excellent communication and presentation skills Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343856
Jan 24, 2020
Amgen Job ID: R-92158 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Compliance Director - US Healthcare to be based in our global headquarters in Thousand Oaks, CA. The Compliance Director will report to the Executive Director of Compliance. The Compliance Director will oversee the Compliance Program at a functional level. Most importantly, this individual will serve as the "face" of WC&BE to the business and will work objectively to provide strategic guidance on compliance issues or concerns within the function. Amgen's Worldwide Compliance and Business Ethics department (WC&BE) consists of a highly qualified and motivated team of professionals who identify, review, evaluate, manage and advise on compliance considerations within the organization. Responsibilities for the Compliance Director include: Advises business leadership in Global Commercial Operations and Corporate Affairs for portions of the US Business Manages day-to-day compliance related questions and issues Ensures policies and standards are understood and followed Ensures alignment and proper communication and training around systems and guidance Identifies potential areas of compliance vulnerability and risk Provides strategic guidance on compliance issues and situations Acts as the channel of communication for compliance related issues Provides training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts Remains abreast of external compliance activities Implements compliance engagement, or where appropriate, corrective action plans Special projects and other duties as assigned Works with other WC&BE teams including, Policy, Training, Communication & Anti-Corruption, Healthcare Compliance Operations, Audit & Monitoring, Investigations, and Regional Compliance Cross-functionally partners with Regulatory Promotions, Legal, Human Resources Domestic travel for this role may be up to 25% Basic Qualifications: Doctorate degree & 4 years of Regulatory and/or Legal and/or Compliance experience OR Master's degree & 7 years of Regulatory and/or Legal and/or Compliance experience OR Bachelor's degree & 9 years of Regulatory and/or Legal and/or Compliance experience Preferred Qualifications: Knowledge of related laws and regulations Understanding of sales, marketing, product promotion, disease education, device regulatory, clinical research and healthcare compliance Pharmaceutical / Biotech industry experience, particularly in Compliance, Legal, Regulatory Affairs, or cross-functional experience in Sales or Marketing, Medical Direct responsibility for counseling and influencing internal clients and cross functional stakeholders Ability to handle ambiguity and complex situations Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude Ability to think strategically and to translate strategy into action plans Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player Ability to work with all levels of management and build relationships across disciplines Excellent communication and presentation skills Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343856
Amgen Job ID: R-90528 Location: Thousand Oaks, CA, US 91360 The Associate Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Responsibilities include: Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures Perform and monitor critical processes Execute routine validation protocols Comply with GMP's Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports) Initiate Quality incidents Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize & accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May train staff to perform hands-on tasks May act as safety representative May participate on cross-functional teams and represent the Purification group Basic Qualifications: Bachelor's degree Or Associate's degree and 4 years of Manufacturing and Operations experience Or High School diploma/GED and 6 years of Manufacturing & Operations experience Preferred Qualifications : Available for non-standard shifts including graveyard shift and weekends Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing CFR and Regulatory knowledge Mechanical ability/expertise Knowledge of WIP lab equipment and computers, with LIMS access Basic statistical mathematical skills Ability to interpret and apply GMP knowledge Understanding of analytical methods for manufacturing area Ability to demonstrate technical writing capability with Trackwise access Able to demonstrate project management skills and presentation skills Ability to understand, apply and evaluate basic chemistry, biology and physical principles Basic troubleshooting skills on Purification equipment Experience with Delta V / automation Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343970
Jan 24, 2020
Amgen Job ID: R-90528 Location: Thousand Oaks, CA, US 91360 The Associate Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Responsibilities include: Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures Perform and monitor critical processes Execute routine validation protocols Comply with GMP's Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports) Initiate Quality incidents Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize & accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May train staff to perform hands-on tasks May act as safety representative May participate on cross-functional teams and represent the Purification group Basic Qualifications: Bachelor's degree Or Associate's degree and 4 years of Manufacturing and Operations experience Or High School diploma/GED and 6 years of Manufacturing & Operations experience Preferred Qualifications : Available for non-standard shifts including graveyard shift and weekends Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing CFR and Regulatory knowledge Mechanical ability/expertise Knowledge of WIP lab equipment and computers, with LIMS access Basic statistical mathematical skills Ability to interpret and apply GMP knowledge Understanding of analytical methods for manufacturing area Ability to demonstrate technical writing capability with Trackwise access Able to demonstrate project management skills and presentation skills Ability to understand, apply and evaluate basic chemistry, biology and physical principles Basic troubleshooting skills on Purification equipment Experience with Delta V / automation Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343970
Amgen Job ID: R-92258 Location: Thousand Oaks, CA, US 91360 Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. The Marketing Operations Sr. Manage r manages all external website design, refresh, deployment & decommissioning projects across the entire Oncology Business Unit (OBU) portfolio. As such, the Marketing Ops Sr. Manager is the primary point of contact & liaison between each OBU Brand Team and its Agency Partners. Primary responsibilities include: Oversight of all OBU Brands websites (40+ sites, detailed list below) GA/Dashboard requests for metrics Project oversight/recommendations for efficiency Lead weekly status updates/calls with Brand & Agency Partners 1:1 weekly touchpoint with Brand Promo MCM Lead Budget management Compliance/Regulatory management Training/support for Marketing partners Day to day website maintenance Content removal, video updates, PDF updates, troubleshooting Technical Quality Assurance (Staging, User Acceptance Testing, Production) PDF's, Videos, Links Website Decommissioning Disable/enable URLs ISM Tickets General development requests for deployment/development teams Initiating of deployment tickets General website maintenance Liaison between OBU Brands & Agency Partners Partner agency alignment Support, guidance, and recommendations on all web initiatives Track and manage to key project timelines & milestones Create workstreams with all partners and internal teams Incorporation of dates for deployments Ensures alignment for web deployments Confirmation of web initiatives in the deployment project queue URL procurement Ensure vendor alignment with Amgen processes & procedures Manages any/all roadblocks & expedited deployment timelines Partner with external agencies for access needs Brightcove IP address whitelisting Internal access Basic Qualifications: Doctorate degree and 2 years of sales and/or marketing operations experience OR Master's degree and 4years of sales and/or marketing operations experience OR Bachelor's degree and 6years of sales and/or marketing operations experience OR Associate's degree and 10 years of sales and/or marketing operations experience OR High school diploma / GED and 12 years of sales and/or marketing operations experience Preferred Qualifications: Experience working with cross-functional teams Experience managing relationships with both internal and external partners Strong oral and written communication skills, including experience with Outlook, Word, Excel, PowerPoint, JIRA, ISM (Service Now) Strong project management skills, including experience with Microsoft Project, Basecamp, Confluence, Google Docs Ability to thrive in a high-performance culture High learning agility and strong willingness to learn Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343532
Jan 24, 2020
Amgen Job ID: R-92258 Location: Thousand Oaks, CA, US 91360 Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. The Marketing Operations Sr. Manage r manages all external website design, refresh, deployment & decommissioning projects across the entire Oncology Business Unit (OBU) portfolio. As such, the Marketing Ops Sr. Manager is the primary point of contact & liaison between each OBU Brand Team and its Agency Partners. Primary responsibilities include: Oversight of all OBU Brands websites (40+ sites, detailed list below) GA/Dashboard requests for metrics Project oversight/recommendations for efficiency Lead weekly status updates/calls with Brand & Agency Partners 1:1 weekly touchpoint with Brand Promo MCM Lead Budget management Compliance/Regulatory management Training/support for Marketing partners Day to day website maintenance Content removal, video updates, PDF updates, troubleshooting Technical Quality Assurance (Staging, User Acceptance Testing, Production) PDF's, Videos, Links Website Decommissioning Disable/enable URLs ISM Tickets General development requests for deployment/development teams Initiating of deployment tickets General website maintenance Liaison between OBU Brands & Agency Partners Partner agency alignment Support, guidance, and recommendations on all web initiatives Track and manage to key project timelines & milestones Create workstreams with all partners and internal teams Incorporation of dates for deployments Ensures alignment for web deployments Confirmation of web initiatives in the deployment project queue URL procurement Ensure vendor alignment with Amgen processes & procedures Manages any/all roadblocks & expedited deployment timelines Partner with external agencies for access needs Brightcove IP address whitelisting Internal access Basic Qualifications: Doctorate degree and 2 years of sales and/or marketing operations experience OR Master's degree and 4years of sales and/or marketing operations experience OR Bachelor's degree and 6years of sales and/or marketing operations experience OR Associate's degree and 10 years of sales and/or marketing operations experience OR High school diploma / GED and 12 years of sales and/or marketing operations experience Preferred Qualifications: Experience working with cross-functional teams Experience managing relationships with both internal and external partners Strong oral and written communication skills, including experience with Outlook, Word, Excel, PowerPoint, JIRA, ISM (Service Now) Strong project management skills, including experience with Microsoft Project, Basecamp, Confluence, Google Docs Ability to thrive in a high-performance culture High learning agility and strong willingness to learn Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117343532
Amgen Job ID: R-91646 Location: Thousand Oaks, CA, US 91360 The Global Medical Affairs Director - Omecamtiv Mecarbil (OM) Companion Diagnostics(cDX) is accountable for the development and execution of global medical affairs strategy for Omecamtiv Mecarbil companion diagnostics. The Global Medical Affairs Director will work closely with cross-functional partners, regions and countries for coordination of all OM companion diagnostic activities and will: Develop and execute the global medical plan for the OM cDx Work with all relevant cross-functional stakeholders to develop the medical affairs strategy for OM cDx Coordinate the OM cDX medical affairs activities in synchronization with the other program activities Partner with regions and countries to execute the OM cDx strategy Lead Scientific Advisory boards and other meetings with Opinion Leaders Conduct individual Opinion Leader and Pathologist interactions Develop and execute the global OL engagement plan and the insights collection plan for the OM cDx Lead the medical OM cDx strategy around major congresses Review Investigator sponsored study (ISS) proposals, collaborative agreements, Real World Evidence, and other types of research proposals concerning the OM companion diagnostics Interact with professional societies and advocacy groups for coordination of activities around OM cDx education and awareness Support partnerships for the global launch preparation and post-launch activities for the OM cDX Partner with all relevant stakeholders for the develop the evidence generation plan and the life cycle management plan for the OM cDx Participate in Diagnostic Development Team meetings for relevant programs Facilitate and continue to build Amgen's role as a science-based, patient-focused partner Determine resource and budget allocation necessary to deliver on global medical strategy Basic Qualifications MD/DO degree from an accredited medical school OR PhD OR PharmD AND 2 years of medical affairs experience or pharmaceutical industry experience Preferred Qualifications MD plus accredited fellowship in Pathology Strong foundation in Life Sciences e.g. Molecular Biology, Pathology Experience with clinical companion diagnostic development 5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers Experience with stakeholder engagement and interactions ( e.g. , OLs, advocacy groups, payers) Familiarity with global regulatory organizations, guidelines, and practices Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs specifically related to companion diagnostics History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale Track record of success collaborating in matrixed cross-functional teams Outstanding written and verbal communication skills Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. MD01 #LI-POST Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117317617
Jan 23, 2020
Amgen Job ID: R-91646 Location: Thousand Oaks, CA, US 91360 The Global Medical Affairs Director - Omecamtiv Mecarbil (OM) Companion Diagnostics(cDX) is accountable for the development and execution of global medical affairs strategy for Omecamtiv Mecarbil companion diagnostics. The Global Medical Affairs Director will work closely with cross-functional partners, regions and countries for coordination of all OM companion diagnostic activities and will: Develop and execute the global medical plan for the OM cDx Work with all relevant cross-functional stakeholders to develop the medical affairs strategy for OM cDx Coordinate the OM cDX medical affairs activities in synchronization with the other program activities Partner with regions and countries to execute the OM cDx strategy Lead Scientific Advisory boards and other meetings with Opinion Leaders Conduct individual Opinion Leader and Pathologist interactions Develop and execute the global OL engagement plan and the insights collection plan for the OM cDx Lead the medical OM cDx strategy around major congresses Review Investigator sponsored study (ISS) proposals, collaborative agreements, Real World Evidence, and other types of research proposals concerning the OM companion diagnostics Interact with professional societies and advocacy groups for coordination of activities around OM cDx education and awareness Support partnerships for the global launch preparation and post-launch activities for the OM cDX Partner with all relevant stakeholders for the develop the evidence generation plan and the life cycle management plan for the OM cDx Participate in Diagnostic Development Team meetings for relevant programs Facilitate and continue to build Amgen's role as a science-based, patient-focused partner Determine resource and budget allocation necessary to deliver on global medical strategy Basic Qualifications MD/DO degree from an accredited medical school OR PhD OR PharmD AND 2 years of medical affairs experience or pharmaceutical industry experience Preferred Qualifications MD plus accredited fellowship in Pathology Strong foundation in Life Sciences e.g. Molecular Biology, Pathology Experience with clinical companion diagnostic development 5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers Experience with stakeholder engagement and interactions ( e.g. , OLs, advocacy groups, payers) Familiarity with global regulatory organizations, guidelines, and practices Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs specifically related to companion diagnostics History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale Track record of success collaborating in matrixed cross-functional teams Outstanding written and verbal communication skills Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. MD01 #LI-POST Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117317617
Amgen Job ID: R-91672 Location: Thousand Oaks, CA, US 91360 The Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for Amgen's commercial products. The position will be a great opportunity to help design, establish and build a high-performing team and capability that will support the end-to-end variation management process. Holistically, this group will be focused on robust project, portfolio, and process management for variations to capture and accelerate the value of change to our commercial products. Effective management of post-launch changes to Amgen's products "variations" is critical. This is especially true given the continued forecasted growth in Amgen's product portfolio and international expansion. Drivers of product change are quite varied and include but are not limited to: response to patient safety issues, regulatory commitments, addressing supply requirements, manufacturing network strategy, commercial or regional strategy, labeling changes, and operational excellence projects. The scope of the variation management process directionally includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, content authoring, publishing, submission, and approval from global regulatory agencies. Key Responsibilities: Represent Variation Management Organization (VMO) on PDT(s), guide stakeholders through process and lead business case development Lead cross-functional stakeholders in development of global variation project plans Drive end-to-end execution of a PDT's portfolio of variation projects (from business case through global regulatory approvals) Communicate priorities to product, functional, and regional stakeholders, identify and resolve issues, escalate to appropriate governance as needed Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes Shepard variations through governance process Standardize and integrate project management tools; establish single source of truth for variation status Periodic travel to sites required up to 10%. Basic Qualifications: Doctorate Degree OR Master's degree and 2 years of Operations or Regulatory experience OR Bachelor's degree and 4 years of Operations or Regulatory experience OR Associates degree & 10 years of Operations or Regulatory experience OR High school diploma / GED and 12 years of Operations or Regulatory experience Preferred Qualifications: 6 + years biotech or pharmaceutical industry experience Able to facilitate and influence senior clients and partners Able to successfully manage workload to timelines Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Strong project management, problem-solving, and analytical skills; experience with project management tools Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution Ability to operate in a matrixed or team environment with site, functional, and executive leadership Comfortable in "start-up" environment of a new Amgen group Experience driving decision making using DAI principles Some experience with the "variation management" processes Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117317551
Jan 23, 2020
Amgen Job ID: R-91672 Location: Thousand Oaks, CA, US 91360 The Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for Amgen's commercial products. The position will be a great opportunity to help design, establish and build a high-performing team and capability that will support the end-to-end variation management process. Holistically, this group will be focused on robust project, portfolio, and process management for variations to capture and accelerate the value of change to our commercial products. Effective management of post-launch changes to Amgen's products "variations" is critical. This is especially true given the continued forecasted growth in Amgen's product portfolio and international expansion. Drivers of product change are quite varied and include but are not limited to: response to patient safety issues, regulatory commitments, addressing supply requirements, manufacturing network strategy, commercial or regional strategy, labeling changes, and operational excellence projects. The scope of the variation management process directionally includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, content authoring, publishing, submission, and approval from global regulatory agencies. Key Responsibilities: Represent Variation Management Organization (VMO) on PDT(s), guide stakeholders through process and lead business case development Lead cross-functional stakeholders in development of global variation project plans Drive end-to-end execution of a PDT's portfolio of variation projects (from business case through global regulatory approvals) Communicate priorities to product, functional, and regional stakeholders, identify and resolve issues, escalate to appropriate governance as needed Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes Shepard variations through governance process Standardize and integrate project management tools; establish single source of truth for variation status Periodic travel to sites required up to 10%. Basic Qualifications: Doctorate Degree OR Master's degree and 2 years of Operations or Regulatory experience OR Bachelor's degree and 4 years of Operations or Regulatory experience OR Associates degree & 10 years of Operations or Regulatory experience OR High school diploma / GED and 12 years of Operations or Regulatory experience Preferred Qualifications: 6 + years biotech or pharmaceutical industry experience Able to facilitate and influence senior clients and partners Able to successfully manage workload to timelines Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Strong project management, problem-solving, and analytical skills; experience with project management tools Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution Ability to operate in a matrixed or team environment with site, functional, and executive leadership Comfortable in "start-up" environment of a new Amgen group Experience driving decision making using DAI principles Some experience with the "variation management" processes Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117317551
Amgen Job ID: R-91720 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The team provides process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. The Sr. Engineer will report to the Principal Engineer of Drug Substance Manufacturing. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at ATO site. The Senior Engineer will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. Primary Responsibilities for the Senior Engineer will include the following: Transfer processes and process improvements from the laboratory into the manufacturing facility and between manufacturing sites Provide on-the-floor technical support for successful scale-up Transfer of process technology, and for routine clinical and/or commercial production; lead data trending and advanced statistical process analysis Provide technical support for all process related deviations (NCs), CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility Identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site Presentation of process performance at team and management meetings; process modeling to guide process development activities, identify process implementation issues and drive optimization Technical project management Support of regulatory filings and inspections Basic Qualifications: Doctorate degree OR Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience OR Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience OR Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience OR High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience Preferred Qualifications : •MS in Chemical/Biochemical Engineer or other biological engineering discipline and 3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP) •Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance. •In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations •In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques. •Process validation, process characterization and process monitoring experience •Experience in supporting regulatory inspections •Process development experience in supporting cGMP manufacturing at large scale •Good written and verbal communication skills •Experience in preparing regulatory filings and participation in regulatory inspections •Process development and optimization experience with late stage or commercial products •Process equipment design and evaluation expertise •Experience with risk analysis methodologies •Independently motivated with ability to multi-task and work in teams Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289427
Jan 22, 2020
Amgen Job ID: R-91720 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The team provides process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. The Sr. Engineer will report to the Principal Engineer of Drug Substance Manufacturing. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at ATO site. The Senior Engineer will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. Primary Responsibilities for the Senior Engineer will include the following: Transfer processes and process improvements from the laboratory into the manufacturing facility and between manufacturing sites Provide on-the-floor technical support for successful scale-up Transfer of process technology, and for routine clinical and/or commercial production; lead data trending and advanced statistical process analysis Provide technical support for all process related deviations (NCs), CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility Identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site Presentation of process performance at team and management meetings; process modeling to guide process development activities, identify process implementation issues and drive optimization Technical project management Support of regulatory filings and inspections Basic Qualifications: Doctorate degree OR Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience OR Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience OR Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience OR High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience Preferred Qualifications : •MS in Chemical/Biochemical Engineer or other biological engineering discipline and 3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP) •Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance. •In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations •In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques. •Process validation, process characterization and process monitoring experience •Experience in supporting regulatory inspections •Process development experience in supporting cGMP manufacturing at large scale •Good written and verbal communication skills •Experience in preparing regulatory filings and participation in regulatory inspections •Process development and optimization experience with late stage or commercial products •Process equipment design and evaluation expertise •Experience with risk analysis methodologies •Independently motivated with ability to multi-task and work in teams Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289427
Amgen Job ID: R-92027 Location: Thousand Oaks, CA, US 91360 Under general supervision, the Manufacturing Associate will be responsible for activities including: Complete aseptic filling and formulation operations Operate equipment in a GMP fashion Complete GMP documentation Own QMTS records Comply with safety guidelines, cGMPs (current Good Manufacturing Practices) and other applicable regulatory requirements Participate in lab investigations / audits. Basic Qualifications: Bachelor's degree OR Associate's degree and 4 years of Manufacturing & Operations related experience OR High School diploma/GED and 6 years of Manufacturing & Operations related experience Preferred Qualifications: B.S. in a life science or related field 2 years of work experience in a GMP environment Ability to perform computer operations, such as ability to navigate in MS Office and Excel Ability to operate specialized equipment and computers as appropriate to the individual area Ability to adhere to regulatory requirements, written procedures and safety guidelines Ability to evaluate documentation/data according to company and regulatory guidelines Ability to interact with inspectors (internal and external) Technical writing capabilities Ability to organize work, handle multiple priorities and meet deadlines Demonstrated written and oral communication skills Presentation capabilities Detail oriented as well as flexible and adaptable to changing priorities and requirements Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289313
Jan 22, 2020
Amgen Job ID: R-92027 Location: Thousand Oaks, CA, US 91360 Under general supervision, the Manufacturing Associate will be responsible for activities including: Complete aseptic filling and formulation operations Operate equipment in a GMP fashion Complete GMP documentation Own QMTS records Comply with safety guidelines, cGMPs (current Good Manufacturing Practices) and other applicable regulatory requirements Participate in lab investigations / audits. Basic Qualifications: Bachelor's degree OR Associate's degree and 4 years of Manufacturing & Operations related experience OR High School diploma/GED and 6 years of Manufacturing & Operations related experience Preferred Qualifications: B.S. in a life science or related field 2 years of work experience in a GMP environment Ability to perform computer operations, such as ability to navigate in MS Office and Excel Ability to operate specialized equipment and computers as appropriate to the individual area Ability to adhere to regulatory requirements, written procedures and safety guidelines Ability to evaluate documentation/data according to company and regulatory guidelines Ability to interact with inspectors (internal and external) Technical writing capabilities Ability to organize work, handle multiple priorities and meet deadlines Demonstrated written and oral communication skills Presentation capabilities Detail oriented as well as flexible and adaptable to changing priorities and requirements Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289313
Amgen Job ID: R-92014 Location: Thousand Oaks, CA, US 91360 Responsible for the financial aspects with the outsourced service Provider of Lab Asset Maintenance Program, i.e. developing the yearly budgets collaborating with Amgen's FP&A staff, managing the multiple PO's and invoice management, and managing the financial reports required for good governance. In addition, will support the Expense activities for the Global Facilities Organization. Responsibilities include: Developing the annual budgets with the ISP for each site Managing financial reporting for all the GFO sites and Manufacturing sites for the outsourced contract Disseminating cost information to the different Amgen Operational and FP&A staff to ensure that this cost is captured in their budgets Coordinating the financial forecasting with the ISP and disseminating the forecasts to the Amgen FP&A staff Generate and communicate the monthly updates to each site's Purchase Orders Manage the financial contract obligations with respect to fees, incentives, savings pay-outs, etc. Prepare and support complex modeling of contracts Prepare quarterly budget / forecasts for Net Expense Prepare monthly variance analysis and reconciliations including preparing quarterly accruals Assist in the annual Assessment process Interact with a wide range of leadership and site staff Additional responsibilities may be assigned as needed Includes some travel Basic Qualifications Doctorate degree OR Master's degree in engineering, business management or life science and 3 years of experience in Operations/life science industry OR Bachelor's degree in engineering, business management or life science and 5 years of experience in Operations/life science industry OR Associate's degree & 10 years of experience in Operations/life science OR High school diploma / GED & 12 years of experience in Operations/life science Preferred Qualifications MBA or MS in Industrial Engineering, Supply Chain Management or other engineering disciplines with 5 years of experience in Operations/life science Knowledge of end-to-end supply chain, drug development, and manufacturing processes Leader with a demonstrated ability to develop and work in a high-performing environment Experience in applying Lean Six Sigma tools such as Value Stream Mapping, 5S, Visual Controls, Root Cause Analysis, Kaizen events, Mistake-proofing, Standard Work / Leader Standard Work and Daily Management Systems Ability to communicate and collaborate across various parts of the organization Function effectively on a team whose members together provide leadership, create a collaborative and inclusive environment, establish goals, plan tasks, and meet objectives Ability to operate in a matrixed team in an ever-changing environment Adept in breaking down complex issues into concise analytical packages and executive messages to enable prompt decision making Experience in quantitative and qualitative skills including financial and supply chain analysis Develop and conduct appropriate experimentation, analyze and interpret data, and use judgment to draw conclusions Ability to manage a two to three projects simultaneously while consistently delivering quality end-product. Handle multiple responsibilities, priorities and tasks with minimal direction Strong interest in learning new things, ability to take on tasks with limited information and/or guidance. Ability to learn and become proficient in Analytics and programming tools such as Python, R, Tableau, and Spotfire Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289332
Jan 22, 2020
Amgen Job ID: R-92014 Location: Thousand Oaks, CA, US 91360 Responsible for the financial aspects with the outsourced service Provider of Lab Asset Maintenance Program, i.e. developing the yearly budgets collaborating with Amgen's FP&A staff, managing the multiple PO's and invoice management, and managing the financial reports required for good governance. In addition, will support the Expense activities for the Global Facilities Organization. Responsibilities include: Developing the annual budgets with the ISP for each site Managing financial reporting for all the GFO sites and Manufacturing sites for the outsourced contract Disseminating cost information to the different Amgen Operational and FP&A staff to ensure that this cost is captured in their budgets Coordinating the financial forecasting with the ISP and disseminating the forecasts to the Amgen FP&A staff Generate and communicate the monthly updates to each site's Purchase Orders Manage the financial contract obligations with respect to fees, incentives, savings pay-outs, etc. Prepare and support complex modeling of contracts Prepare quarterly budget / forecasts for Net Expense Prepare monthly variance analysis and reconciliations including preparing quarterly accruals Assist in the annual Assessment process Interact with a wide range of leadership and site staff Additional responsibilities may be assigned as needed Includes some travel Basic Qualifications Doctorate degree OR Master's degree in engineering, business management or life science and 3 years of experience in Operations/life science industry OR Bachelor's degree in engineering, business management or life science and 5 years of experience in Operations/life science industry OR Associate's degree & 10 years of experience in Operations/life science OR High school diploma / GED & 12 years of experience in Operations/life science Preferred Qualifications MBA or MS in Industrial Engineering, Supply Chain Management or other engineering disciplines with 5 years of experience in Operations/life science Knowledge of end-to-end supply chain, drug development, and manufacturing processes Leader with a demonstrated ability to develop and work in a high-performing environment Experience in applying Lean Six Sigma tools such as Value Stream Mapping, 5S, Visual Controls, Root Cause Analysis, Kaizen events, Mistake-proofing, Standard Work / Leader Standard Work and Daily Management Systems Ability to communicate and collaborate across various parts of the organization Function effectively on a team whose members together provide leadership, create a collaborative and inclusive environment, establish goals, plan tasks, and meet objectives Ability to operate in a matrixed team in an ever-changing environment Adept in breaking down complex issues into concise analytical packages and executive messages to enable prompt decision making Experience in quantitative and qualitative skills including financial and supply chain analysis Develop and conduct appropriate experimentation, analyze and interpret data, and use judgment to draw conclusions Ability to manage a two to three projects simultaneously while consistently delivering quality end-product. Handle multiple responsibilities, priorities and tasks with minimal direction Strong interest in learning new things, ability to take on tasks with limited information and/or guidance. Ability to learn and become proficient in Analytics and programming tools such as Python, R, Tableau, and Spotfire Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289332
Amgen Job ID: R-91909 Location: Thousand Oaks, CA, US 91360 Under the direction of the Environmental, Health, Safety and Sustainability (EHSS) Sr. Manager, the successful candidate will be responsible for the implementation, coordination, advancement and support of existing Environmental compliance programs and focus areas at the site level. These may include: aboveground/underground petroleum storage tanks, oil spill prevention, emergency planning and community right-to-know, asbestos/lead, hazardous materials transportation, regulated waste, water quality, air quality, and environmental sustainability. Responsibilities Interpreting complex environmental regulations and developing/maintaining processes that will ensure compliance with Federal, State and local requirements; Interfacing with regulatory agency representatives during on-site inspections and to address program needs; Maintaining appropriate records and documentation; Preparing and submitting required internal and external regulatory reports; Identifying and implementing program improvement opportunities; Partnering with all levels of internal client and site/corporate EHS organizations; Acting as EHSS representative for internal client organizations by executing an EHSS culture program, conducting regular inspections, ensuring changes with potential EHSS impacts are assessed, investigating incidents and proactively assessing risks related to routine and non-routine activities; Participating in emergency response activities; Facilitation of Training Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of EHSS experience OR Associate's degree and 6 years of EHSS experience OR High school diploma / GED and 8 years of EHSS experience Preferred Qualifications: Bachelor's degree in environmental, safety, technical, scientific or engineering fields. 3 + years of experience developing and supporting EHSS programs or other technical programs including 2+ years with environmental management systems and programs related to hazardous materials storage and transportation, water quality, regulated waste, air quality or environmental sustainability. Proficiency with Microsoft (MS) Excel, Word, and PowerPoint. 5 + years of experience interpreting regulatory requirements, developing and supporting EHS environmental compliance programs or other technical programs; Current California Underground Storage Tank Operator Certification; Experience interfacing with regulatory agency representatives during on-site inspections and to address program needs; Current qualification as a Hazardous Material Technician under the Federal HAZWOPER standard The ideal candidate is enthusiastic, creative, and professional with excellent communication skills and a strong desire to learn. Advanced skills working with MS Excel. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289351
Jan 22, 2020
Amgen Job ID: R-91909 Location: Thousand Oaks, CA, US 91360 Under the direction of the Environmental, Health, Safety and Sustainability (EHSS) Sr. Manager, the successful candidate will be responsible for the implementation, coordination, advancement and support of existing Environmental compliance programs and focus areas at the site level. These may include: aboveground/underground petroleum storage tanks, oil spill prevention, emergency planning and community right-to-know, asbestos/lead, hazardous materials transportation, regulated waste, water quality, air quality, and environmental sustainability. Responsibilities Interpreting complex environmental regulations and developing/maintaining processes that will ensure compliance with Federal, State and local requirements; Interfacing with regulatory agency representatives during on-site inspections and to address program needs; Maintaining appropriate records and documentation; Preparing and submitting required internal and external regulatory reports; Identifying and implementing program improvement opportunities; Partnering with all levels of internal client and site/corporate EHS organizations; Acting as EHSS representative for internal client organizations by executing an EHSS culture program, conducting regular inspections, ensuring changes with potential EHSS impacts are assessed, investigating incidents and proactively assessing risks related to routine and non-routine activities; Participating in emergency response activities; Facilitation of Training Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of EHSS experience OR Associate's degree and 6 years of EHSS experience OR High school diploma / GED and 8 years of EHSS experience Preferred Qualifications: Bachelor's degree in environmental, safety, technical, scientific or engineering fields. 3 + years of experience developing and supporting EHSS programs or other technical programs including 2+ years with environmental management systems and programs related to hazardous materials storage and transportation, water quality, regulated waste, air quality or environmental sustainability. Proficiency with Microsoft (MS) Excel, Word, and PowerPoint. 5 + years of experience interpreting regulatory requirements, developing and supporting EHS environmental compliance programs or other technical programs; Current California Underground Storage Tank Operator Certification; Experience interfacing with regulatory agency representatives during on-site inspections and to address program needs; Current qualification as a Hazardous Material Technician under the Federal HAZWOPER standard The ideal candidate is enthusiastic, creative, and professional with excellent communication skills and a strong desire to learn. Advanced skills working with MS Excel. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289351
Amgen Job ID: R-91783 Location: Thousand Oaks, CA, US 91360 The Corporate Facilities and Engineering Manager will be responsible for providing Maintenance Subject Matter Expertise across Amgen sites. The role is part of the Facilities Center of Excellence (COE) team within the Global Facilities Operations (GFO) Group. The COE is a team of Subject Matter Experts (SME) that provides technical operations, maintenance expertise, technical reports, data analysis, metrics and project support. The primary focus of this position will be the SME for Maintenance, Operations and Facility Services across multiple Amgen sites. The Corporate Facilities and Engineering Manager will also be responsible for conducting periodic operational assessments to ensure the achievement of the service contract requirements. The Corporate Facilities and Engineering Manager will actively communicate and work with multiple client groups at a variety of management levels within the organization forming alignment in business processes and strategies on a daily basis. Responsibilities include: Provide subject matter maintenance expertise to the network for utility systems and other mechanical systems. System ownership including maintenance of systems, CAD drawings, GMP change control, development of maintenance plans and oversight of system performance. Purposeful presence on the floor including walk down of equipment, safety inspections etc. Perform data extraction and analysis from the Amgen Computerized Maintenance Management System (CMMS) Work within GMP facilities including strong understanding of regulatory requirements related to facility systems in GMP areas. Sharing Best Practices, and support for problem solving Own and Manage multiple CMMS Job Plans Own and manage multiple GMP Standards and support Documents Interacts with business partners and internal/external customers and clients Identifies and implements process and safety improvements Support Global Networks such as Maintenance, Utilities and Pest Control Basic Qualifications: Doctorate Degree OR Master's Degree and 2 years of Engineering/Facilities Management experience OR Bachelor's Degree and 4 years of Engineering/Facilities Management experience OR Associate's degree and 10 years of Engineering/Facilities Management experience OR High school diploma/GED and 12 years of Engineering/Facilities Management experience. Preferred Qualifications : Facilities management knowledge - A good understanding of Facility Operations, Maintenance and pest control Experience of industry Best Practices for mechanical maintenance Experience with benchmarking Ability to read and understand various CAD drawings including single line and P&ID drawings Ability to translate and communicate detailed data analysis to all levels of the organization and staff with varying levels of knowledge and experience Computerized Maintenance Management System, experience with Maximo would be a plus Communication Skills - Ability to effectively communicate with a varied client base including maintenance groups, service providers, project team members and management Process Improvement Skills - Working knowledge of continuous improvement and operational excellence methods and best practices Team Player - Ability to work collaboratively on various project teams Strong time management, organizational skills and ability to manage multiple complex tasks 5 years' experience in engineering and/or facilities management in a corporate environment. Ability to effectively influence cross-functionally and across multiple levels of the organization. Ability to work independently with minimal supervision Strong computer skills including advanced use of Microsoft office Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289370
Jan 22, 2020
Amgen Job ID: R-91783 Location: Thousand Oaks, CA, US 91360 The Corporate Facilities and Engineering Manager will be responsible for providing Maintenance Subject Matter Expertise across Amgen sites. The role is part of the Facilities Center of Excellence (COE) team within the Global Facilities Operations (GFO) Group. The COE is a team of Subject Matter Experts (SME) that provides technical operations, maintenance expertise, technical reports, data analysis, metrics and project support. The primary focus of this position will be the SME for Maintenance, Operations and Facility Services across multiple Amgen sites. The Corporate Facilities and Engineering Manager will also be responsible for conducting periodic operational assessments to ensure the achievement of the service contract requirements. The Corporate Facilities and Engineering Manager will actively communicate and work with multiple client groups at a variety of management levels within the organization forming alignment in business processes and strategies on a daily basis. Responsibilities include: Provide subject matter maintenance expertise to the network for utility systems and other mechanical systems. System ownership including maintenance of systems, CAD drawings, GMP change control, development of maintenance plans and oversight of system performance. Purposeful presence on the floor including walk down of equipment, safety inspections etc. Perform data extraction and analysis from the Amgen Computerized Maintenance Management System (CMMS) Work within GMP facilities including strong understanding of regulatory requirements related to facility systems in GMP areas. Sharing Best Practices, and support for problem solving Own and Manage multiple CMMS Job Plans Own and manage multiple GMP Standards and support Documents Interacts with business partners and internal/external customers and clients Identifies and implements process and safety improvements Support Global Networks such as Maintenance, Utilities and Pest Control Basic Qualifications: Doctorate Degree OR Master's Degree and 2 years of Engineering/Facilities Management experience OR Bachelor's Degree and 4 years of Engineering/Facilities Management experience OR Associate's degree and 10 years of Engineering/Facilities Management experience OR High school diploma/GED and 12 years of Engineering/Facilities Management experience. Preferred Qualifications : Facilities management knowledge - A good understanding of Facility Operations, Maintenance and pest control Experience of industry Best Practices for mechanical maintenance Experience with benchmarking Ability to read and understand various CAD drawings including single line and P&ID drawings Ability to translate and communicate detailed data analysis to all levels of the organization and staff with varying levels of knowledge and experience Computerized Maintenance Management System, experience with Maximo would be a plus Communication Skills - Ability to effectively communicate with a varied client base including maintenance groups, service providers, project team members and management Process Improvement Skills - Working knowledge of continuous improvement and operational excellence methods and best practices Team Player - Ability to work collaboratively on various project teams Strong time management, organizational skills and ability to manage multiple complex tasks 5 years' experience in engineering and/or facilities management in a corporate environment. Ability to effectively influence cross-functionally and across multiple levels of the organization. Ability to work independently with minimal supervision Strong computer skills including advanced use of Microsoft office Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117289370
Amgen Job ID: R-91484 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a motivated Senior Associate Scientist with experience in the field of single-cell sorting and analysis as applied to research and clinical arenas that utilize human blood specimens or other relevant tissues. This role is laboratory-centered in a dynamic core facility. The Sr. Associate Scientist will work with moderate supervision and will integrate activities with many scientists that access the core laboratory resource. As part of a multi-disciplinary team, they will be accountable for high quality deliverables as related to cell sorting and immunophenotyping while exhibiting and enforcing safe working practices throughout. A major emphasis of this position is to embrace a role of continuous self-improvement and self-motivation in a team-oriented environment to increase practical scientific abilities - as well as improving the quality of science generated from the facility. The Cytometry Sciences group at Amgen Thousand Oaks is responsible for the maintenance and operation of a variety of flow cytometry analyzers and cell sorters that are routinely accessed by many scientists for the purpose of interrogating cell biology. Amgen Thousand Oaks represents an excellent opportunity for a motivated and outgoing flow cytometrist who is energized by interacting with others in a multifaceted and fast-paced setting, sharing the common goal to develop therapeutics designed to address unmet medical needs. Position Responsibilities Include: Calibrate and operate multiparameter flow cytometers, including cell sorters Identify instrument problems and perform basic troubleshooting / remediation Work in a biosafety level 2 plus laboratory environment Basic Qualifications Master's degree and 3 years of scientific experience OR Bachelor's degree and 5 years of scientific experience Preferred Qualifications Education in the life sciences Prior experience working in a biopharmaceutical company Background in cytometry A working knowledge of good documentation practices and scientific conduct as defined by standard operating procedures Prior experience designing high complexity (10 plus color) staining panels A working knowledge of Becton Dickinson flow cytometers and software Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244053
Jan 19, 2020
Amgen Job ID: R-91484 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a motivated Senior Associate Scientist with experience in the field of single-cell sorting and analysis as applied to research and clinical arenas that utilize human blood specimens or other relevant tissues. This role is laboratory-centered in a dynamic core facility. The Sr. Associate Scientist will work with moderate supervision and will integrate activities with many scientists that access the core laboratory resource. As part of a multi-disciplinary team, they will be accountable for high quality deliverables as related to cell sorting and immunophenotyping while exhibiting and enforcing safe working practices throughout. A major emphasis of this position is to embrace a role of continuous self-improvement and self-motivation in a team-oriented environment to increase practical scientific abilities - as well as improving the quality of science generated from the facility. The Cytometry Sciences group at Amgen Thousand Oaks is responsible for the maintenance and operation of a variety of flow cytometry analyzers and cell sorters that are routinely accessed by many scientists for the purpose of interrogating cell biology. Amgen Thousand Oaks represents an excellent opportunity for a motivated and outgoing flow cytometrist who is energized by interacting with others in a multifaceted and fast-paced setting, sharing the common goal to develop therapeutics designed to address unmet medical needs. Position Responsibilities Include: Calibrate and operate multiparameter flow cytometers, including cell sorters Identify instrument problems and perform basic troubleshooting / remediation Work in a biosafety level 2 plus laboratory environment Basic Qualifications Master's degree and 3 years of scientific experience OR Bachelor's degree and 5 years of scientific experience Preferred Qualifications Education in the life sciences Prior experience working in a biopharmaceutical company Background in cytometry A working knowledge of good documentation practices and scientific conduct as defined by standard operating procedures Prior experience designing high complexity (10 plus color) staining panels A working knowledge of Becton Dickinson flow cytometers and software Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244053
Amgen Job ID: R-91869 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Salesforce Developer at our Tampa, FL or Thousand Oaks, CA location to join the Global Commercial Operations Information Systems (GCOIS) group as Salesforce Developer. The Developer will be part of the Patient Support Services (PSP) product team to deliver technology services and solutions that achieve strategies and business goals including insights and analytics on the Pulse Service platform. This position is responsible for crafting and building secure, scalable solutions on the Salesforce.com (SFDC) Platform working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. The Analyst will chip into the development of the PSP Platform at Amgen. You will stay abreast to the Salesforce roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. The Salesforce Developer will collaborate with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities Ability to think strategically about technology and recommend solutions that align with patient services strategy and achieve the greatest business impact Support the development of our patient data connections, both real-time and batch, between Amgen's patient Customer Relationship Management solution, the Patient Master, the Consent Management system, and all patient websites, mobile apps, support services (copay, call center, nurse programs, etc.), and fulfillment vendors Handle day to day development activities on the salesforce.com platform using Apex, Visual Force, Lightning Web Components and Aura Support the creation of customizations and integrations required to solution delivery Configure the Salesforce.com application based on the business requirements Model new custom objects and fields to support business requirements Develop custom applications using APEX, JavaScript, Visual Force, AJAX, HTML, CSS Apply standard methodologies and experience to build Salesforce.com applications Understand Salesforce security and apply the Organization-Wide Default, sharing patterns, profiles or permissions to your applications Communicate software and system designs using UML, lucid chart or other modeling tools and software. Collaborate with team members to apply abstractions and service-orientation to foster scalability Develop test classes and automation to validate business logic and avoid production issues Work closely with other developers in the team including business analyst, QA analyst and project managers Research Salesforce.com capabilities as needed to suit business requirements, and provide a gap analysis Develop estimates for projects Basic Qualifications Master's degree OR Bachelor's degree and 2 years of Information Systems experience OR Associate's degree and 6 years of Information Systems experience OR High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications Ability to work in a changing environment and handle multiple projects simultaneously Superb interpersonal skills to work across and up through the organization, including escalation and mitigation of issues, risks, and business impacts Advanced problem-solving capabilities and the ability to use constraints as opportunities Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Experience with Tableau and other reporting and analytics tools 1+ years of experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards 2+ years of working with clients and vendors developing solutions and supporting projects from requirements capturing to release management Experience integrating Salesforce.com with other applications Experience with Amazon Web Services and/or Amazon Connect Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244157
Jan 19, 2020
Amgen Job ID: R-91869 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Salesforce Developer at our Tampa, FL or Thousand Oaks, CA location to join the Global Commercial Operations Information Systems (GCOIS) group as Salesforce Developer. The Developer will be part of the Patient Support Services (PSP) product team to deliver technology services and solutions that achieve strategies and business goals including insights and analytics on the Pulse Service platform. This position is responsible for crafting and building secure, scalable solutions on the Salesforce.com (SFDC) Platform working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. The Analyst will chip into the development of the PSP Platform at Amgen. You will stay abreast to the Salesforce roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. The Salesforce Developer will collaborate with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities Ability to think strategically about technology and recommend solutions that align with patient services strategy and achieve the greatest business impact Support the development of our patient data connections, both real-time and batch, between Amgen's patient Customer Relationship Management solution, the Patient Master, the Consent Management system, and all patient websites, mobile apps, support services (copay, call center, nurse programs, etc.), and fulfillment vendors Handle day to day development activities on the salesforce.com platform using Apex, Visual Force, Lightning Web Components and Aura Support the creation of customizations and integrations required to solution delivery Configure the Salesforce.com application based on the business requirements Model new custom objects and fields to support business requirements Develop custom applications using APEX, JavaScript, Visual Force, AJAX, HTML, CSS Apply standard methodologies and experience to build Salesforce.com applications Understand Salesforce security and apply the Organization-Wide Default, sharing patterns, profiles or permissions to your applications Communicate software and system designs using UML, lucid chart or other modeling tools and software. Collaborate with team members to apply abstractions and service-orientation to foster scalability Develop test classes and automation to validate business logic and avoid production issues Work closely with other developers in the team including business analyst, QA analyst and project managers Research Salesforce.com capabilities as needed to suit business requirements, and provide a gap analysis Develop estimates for projects Basic Qualifications Master's degree OR Bachelor's degree and 2 years of Information Systems experience OR Associate's degree and 6 years of Information Systems experience OR High school diploma / GED and 8 years of Information Systems experience Preferred Qualifications Ability to work in a changing environment and handle multiple projects simultaneously Superb interpersonal skills to work across and up through the organization, including escalation and mitigation of issues, risks, and business impacts Advanced problem-solving capabilities and the ability to use constraints as opportunities Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Experience with Tableau and other reporting and analytics tools 1+ years of experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards 2+ years of working with clients and vendors developing solutions and supporting projects from requirements capturing to release management Experience integrating Salesforce.com with other applications Experience with Amazon Web Services and/or Amazon Connect Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244157
Amgen Job ID: R-91868 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Senior MuleSoft Developer at our Thousand Oaks, CA or Tampa, FL office to join the Global Commercial Operations Information Systems group. The resource will be part of the Patient Support Services product team to deliver technology services and solutions that achieve Amgen's Patient Support Services strategies and business goals including insights and analytics on the Pulse Service platform. Partners with the US Sales and Marketing teams to deliver solutions that engage our customers. This role will service US Business Operations. In this role, you will be crafting and building secure, scalable integrations on MuleSoft by working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. Will be required to stay abreast to the MuleSoft roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. Will be working with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities: Ability to think strategically about technology and recommend/develop solutions that align with patient services strategy and achieve the greatest business impact Be responsible for the development of our patient data connections, both real-time and batch, between Patient Support platform, Patient and Provider Marketing platform, MDM's and 3rd party service providers Extensive hands-on technical and solution implementation experience with MuleSoft Anypoint Platform and Studio, demonstrating positions of growing responsibility and management/mentoring of more junior technical resources Research MuleSoft capabilities as needed to suit business requirements, and provide a gap analysis A detailed understanding of web services, data modelling, RDMS, SQL and enterprise application integration concepts, including experience with enterprise integration tools (ESBs and/or ETL tools), and common integration design patterns with enterprise systems (e.g. CMS, ERP, HRIS, DWH/DM) Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Communicate software and system designs using UML, lucid chart or other modelling tools and software. Collaborate with team members to apply abstractions and service-orientation to further scalability Basic Qualifications: Doctorate OR Master's degree and 3 years of Information Systems and/or Computer Science experience OR Bachelor's degree and 5 years of Information Systems and/or Computer Science experience OR Associate's degree and 10 years of Information Systems and/or Computer Science experience OR High school diploma / GED and 12 years of Information Systems and/or Computer Science experience Preferred Qualifications: Certificates MuleSoft Certified Integration Architect Level 1, MuleSoft Certified Developer - Level 1 5+ years of application design and development experience in MuleSoft 2+ years of working with clients and vendors developing solutions and supporting projects from requirements gathering to release management Experience in AWS data bricks, AWS Air Flow, AWS Lambda, AWS S3 and AWS IDM Experience integrating Salesforce.com with other applications using MuleSoft Experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual-Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards Experience with AWS and/or Amazon Connect Validated project management and business analyst skills and experience Experience with Tableau and other reporting and analytics tools Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244187
Jan 19, 2020
Amgen Job ID: R-91868 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Senior MuleSoft Developer at our Thousand Oaks, CA or Tampa, FL office to join the Global Commercial Operations Information Systems group. The resource will be part of the Patient Support Services product team to deliver technology services and solutions that achieve Amgen's Patient Support Services strategies and business goals including insights and analytics on the Pulse Service platform. Partners with the US Sales and Marketing teams to deliver solutions that engage our customers. This role will service US Business Operations. In this role, you will be crafting and building secure, scalable integrations on MuleSoft by working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. Will be required to stay abreast to the MuleSoft roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. Will be working with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities: Ability to think strategically about technology and recommend/develop solutions that align with patient services strategy and achieve the greatest business impact Be responsible for the development of our patient data connections, both real-time and batch, between Patient Support platform, Patient and Provider Marketing platform, MDM's and 3rd party service providers Extensive hands-on technical and solution implementation experience with MuleSoft Anypoint Platform and Studio, demonstrating positions of growing responsibility and management/mentoring of more junior technical resources Research MuleSoft capabilities as needed to suit business requirements, and provide a gap analysis A detailed understanding of web services, data modelling, RDMS, SQL and enterprise application integration concepts, including experience with enterprise integration tools (ESBs and/or ETL tools), and common integration design patterns with enterprise systems (e.g. CMS, ERP, HRIS, DWH/DM) Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Communicate software and system designs using UML, lucid chart or other modelling tools and software. Collaborate with team members to apply abstractions and service-orientation to further scalability Basic Qualifications: Doctorate OR Master's degree and 3 years of Information Systems and/or Computer Science experience OR Bachelor's degree and 5 years of Information Systems and/or Computer Science experience OR Associate's degree and 10 years of Information Systems and/or Computer Science experience OR High school diploma / GED and 12 years of Information Systems and/or Computer Science experience Preferred Qualifications: Certificates MuleSoft Certified Integration Architect Level 1, MuleSoft Certified Developer - Level 1 5+ years of application design and development experience in MuleSoft 2+ years of working with clients and vendors developing solutions and supporting projects from requirements gathering to release management Experience in AWS data bricks, AWS Air Flow, AWS Lambda, AWS S3 and AWS IDM Experience integrating Salesforce.com with other applications using MuleSoft Experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual-Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards Experience with AWS and/or Amazon Connect Validated project management and business analyst skills and experience Experience with Tableau and other reporting and analytics tools Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244187
Amgen Job ID: R-91867 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Senior MuleSoft Developer at our Thousand Oaks, CA or Tampa, FL office to join the Global Commercial Operations Information Systems group. The resource will be part of the Patient Support Services product team to deliver technology services and solutions that achieve Amgen's Patient Support Services strategies and business goals including insights and analytics on the Pulse Service platform. Partners with the US Sales and Marketing teams to deliver solutions that engage our customers. This role will service US Business Operations. In this role, you will be crafting and building secure, scalable integrations on MuleSoft by working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. Will be required to stay abreast to the MuleSoft roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. Will be working with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities: Ability to think strategically about technology and recommend/develop solutions that align with patient services strategy and achieve the greatest business impact Be responsible for the development of our patient data connections, both real-time and batch, between Patient Support platform, Patient and Provider Marketing platform, MDM's and 3rd party service providers Extensive hands-on technical and solution implementation experience with MuleSoft Anypoint Platform and Studio, demonstrating positions of growing responsibility and management/mentoring of more junior technical resources Research MuleSoft capabilities as needed to suit business requirements, and provide a gap analysis A detailed understanding of web services, data modelling, RDMS, SQL and enterprise application integration concepts, including experience with enterprise integration tools (ESBs and/or ETL tools), and common integration design patterns with enterprise systems (e.g. CMS, ERP, HRIS, DWH/DM) Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Communicate software and system designs using UML, lucid chart or other modelling tools and software. Collaborate with team members to apply abstractions and service-orientation to further scalability Basic Qualifications: Doctorate OR Master's degree and 3 years of Information Systems and/or Computer Science experience OR Bachelor's degree and 5 years of Information Systems and/or Computer Science experience OR Associate's degree and 10 years of Information Systems and/or Computer Science experience OR High school diploma / GED and 12 years of Information Systems and/or Computer Science experience Preferred Qualifications: Certificates MuleSoft Certified Integration Architect Level 1, MuleSoft Certified Developer - Level 1 5+ years of application design and development experience in MuleSoft 2+ years of working with clients and vendors developing solutions and supporting projects from requirements gathering to release management Experience in AWS data bricks, AWS Air Flow, AWS Lambda, AWS S3 and AWS IDM Experience integrating Salesforce.com with other applications using MuleSoft Experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual-Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards Experience with AWS and/or Amazon Connect Validated project management and business analyst skills and experience Experience with Tableau and other reporting and analytics tools Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244208
Jan 19, 2020
Amgen Job ID: R-91867 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Florida - Tampa Amgen is seeking a Senior MuleSoft Developer at our Thousand Oaks, CA or Tampa, FL office to join the Global Commercial Operations Information Systems group. The resource will be part of the Patient Support Services product team to deliver technology services and solutions that achieve Amgen's Patient Support Services strategies and business goals including insights and analytics on the Pulse Service platform. Partners with the US Sales and Marketing teams to deliver solutions that engage our customers. This role will service US Business Operations. In this role, you will be crafting and building secure, scalable integrations on MuleSoft by working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with standard methodologies. Will be required to stay abreast to the MuleSoft roadmap and capabilities, provide feedback to and develop standard methodologies, optimize engineering or release processes. Will be working with various teams such as program management, development teams, operations, customer service, sales, brand/marketing, legal, and safety, to lend clarification and support to requirements definition at all stages of the product life cycle. Responsibilities: Ability to think strategically about technology and recommend/develop solutions that align with patient services strategy and achieve the greatest business impact Be responsible for the development of our patient data connections, both real-time and batch, between Patient Support platform, Patient and Provider Marketing platform, MDM's and 3rd party service providers Extensive hands-on technical and solution implementation experience with MuleSoft Anypoint Platform and Studio, demonstrating positions of growing responsibility and management/mentoring of more junior technical resources Research MuleSoft capabilities as needed to suit business requirements, and provide a gap analysis A detailed understanding of web services, data modelling, RDMS, SQL and enterprise application integration concepts, including experience with enterprise integration tools (ESBs and/or ETL tools), and common integration design patterns with enterprise systems (e.g. CMS, ERP, HRIS, DWH/DM) Working understanding of Agile, Scrum, Design Thinking, and Lean Startup principles Communicate software and system designs using UML, lucid chart or other modelling tools and software. Collaborate with team members to apply abstractions and service-orientation to further scalability Basic Qualifications: Doctorate OR Master's degree and 3 years of Information Systems and/or Computer Science experience OR Bachelor's degree and 5 years of Information Systems and/or Computer Science experience OR Associate's degree and 10 years of Information Systems and/or Computer Science experience OR High school diploma / GED and 12 years of Information Systems and/or Computer Science experience Preferred Qualifications: Certificates MuleSoft Certified Integration Architect Level 1, MuleSoft Certified Developer - Level 1 5+ years of application design and development experience in MuleSoft 2+ years of working with clients and vendors developing solutions and supporting projects from requirements gathering to release management Experience in AWS data bricks, AWS Air Flow, AWS Lambda, AWS S3 and AWS IDM Experience integrating Salesforce.com with other applications using MuleSoft Experience developing and customizing Salesforce.com application via web services, Apex, SOQL, Aura, Lightning Web Components, Visual-Force, Visual Studio Code, IDE, Data Loader, Reports and Dashboards Experience with AWS and/or Amazon Connect Validated project management and business analyst skills and experience Experience with Tableau and other reporting and analytics tools Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. PI117244208