8 jobs found

Amgen Job ID: R-89408 Location: West Greenwich, RI, US 02817 Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial operations across a large number of key products for the company. The Manager Manufacturing is responsible for leading a team in production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role will leverage continuous improvement, transformative approaches and innovation to drive reliability, efficiency, agility and differentiation. The manager will champion a safe and compliant production environment through structured on floor presence. The initial focus of this role will be part of the Amgen's next-generation manufacturing facility (AR30) startup team on Admin Day shift to prepare the plant for Operational Readiness (up to 6 months). This includes but is not limited to hiring the manufacturing execution team, developing training, revising documentation, and creating strategies to ensure right first time execution on the production floor. After the initial phase, the successful incumbent will be expected to join and lead a shift team working a 12-hour shift. This position is for the night shift. The shift pattern will be 7PM-7AM structure with a rotation covering 7 days per week. Responsibilities: Create a culture of safety, quality, and continuous improvement Oversee right first time on the floor execution of the production plan Deliver strong business results Develop a high performing team, build technical and leadership capabilities within the organization to meet current and future business needs Ensure the right people and resources are in place and optimally allocated to achieve results Create an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing Ensure effective decision-making Overseeing manufacturing validation activities Responsible for overseeing new technology implementation in manufacturing Attracting, developing and retaining diverse talent Conducts short and long-range talent planning to ensure readiness of talent to execute future organizational objectives Works across functions to build organization and individual capabilities Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance Basic Qualifications: Doctorate Degree OR Master's Degree and 3 years of Manufacturing and Operations experience OR Bachelor's Degree and 5 years of Manufacturing and Operations experience OR Associate's degree and 10 years of Manufacturing and Operations experience OR High school diploma/GED and 12 years of Manufacturing and Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Bachelor's degree in Life Sciences or Engineering Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing Strong knowledge cleaning and sterilization validation In depth experience with New Product Introduction and technology transfer Strong leadership and teambuilding skills (coaching, mentoring, counseling) Experience with Lean Principles and continuous improvement Experience with performance management including conflict resolution and performance reviews Analytical problem-solving skills Project Management skills Thorough understanding of regulatory requirements Ability to be flexible and manage change Excellent verbal and written communication (technical) 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. PI116336420

Amgen Job ID: R-90028 Location: Juncos, PR, US 00777 Come and Grow with us! We are looking for creative, highly motivated and hardworking Undergrad student for a paid Co-op opportunity in our manufacturing operation - Amgen Manufacturing Limited at Juncos, Puerto Rico. The student will support Plant Operational Readiness Department within the AML6 Drug Substance facilities. AML is Amgen's largest manufacturing site and the majority of products comprising Amgen's current portfolio move through this outstanding biotechnology manufacturing facility. The AML Campus is a network within the Amgen manufacturing network. It includes 6 manufacturing plants: a mammalian and a microbial bulk plants, a formulation and filling plant, a packaging plant and a small molecule solid dosage manufacturing plant. What you will do... This is an exceptional opportunity to gain learning and exposure to cutting edge technology and advance processes that form the foundation of our state-of-the-art biotechnology facility. As an Undergrad Co-op you will be able to apply coursework concepts to real-world situations working alongside professional, expert colleagues while also gaining valuable experience working for a global manufacturing company. This opportunity will require to support the Department's projects, activities and daily operations through the use of related technical concepts and tools. The temporary CO-OP assignment will be supporting the Operational Readiness AML6 Department for six months, based on business needs and can be extended up to one year. Positions will be required to begin in January 2020. In order to do so, you need good analytical and technical skills as well as good verbal and written communication skills. You will also required to work independently and be ambitious with a strong desire to learn. Your time with us will look something like this... Perform meetings to provide status of assigned projects Portrait information using Power Point, Excel, Word and MS Project Assist in generation of Plant Operational Readiness Tools Meet milestones and deliver high quality results Support special projects Improving operational efficiency and productivity Identifying and implementing new process across departments/functions Support the implementation of solutions of process improvement opportunities, special projects or initiatives Participate in continuous improvement initiatives (Kaizen, critiques, VSMs…) Ability to evaluate documentation and operations according to company procedures Interact constructively with peers Work with minimum supervision Other functions could be designated in alignment with business needs What you will get... Along with competitive pay, we offer you a flexible work schedule with a maximum of 40 hours per week that you can accommodate to your academic schedule if needed. For this opportunity you will need to... Pursuing a Bachelor's degree in Life Science or Biotechnology. At Least 3.00 GPA or greater preferred. Be currently enrolled in a degreed college/university program. Preferred qualifications Skills in: Collaboration, negotiation, persuasion, basic project management, ensuring completion and follow up. Leadership skills Basic understanding of cGMPs Good communication skills (both written and verbal in Spanish and English) Well Organized with efficient time management skills Passionate about learning new concepts and work processes Computer literacy (Excel Programming, Word, Power Point and Visio) Ability to work as a team player and/or independently with good interpersonal skills Demonstrate the ability to prioritize and meet deadlines Basic word processing, presentation and spreadsheet application skills Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities. 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. PI116336631

Amgen Job ID: R-89618 Location: West Greenwich, RI, US 02817 NightShift: (7:00pm - 7:00am rotating nights) The Manager Manufacturing position is within the Solutions Preparation organization (Media and Buffers) at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The Manager will collaborate with multiple functions on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility and site. The Manager is responsible for leading on the floor operations and staff in manufacturing. Responsible for supervising, coaching, hiring, and development of floor staff. The Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short and long term Amgen Operational goals. Responsibilities: Ensure safe working environment. Ensure cGMP and CFR compliance of operating areas. Resolve problems during operation. Elevate critical and impactful events to Sr. management and make real time processing decisions. Participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor. Develop, implement and assess solutions for complex problems. Ensure scheduling of production and maintenance activities. Collaborate with cross-functional teams (i.e. QA/QC, F&E, PD, Regulatory, etc.) in completing production activities and ensuring schedule adherence. Interact with business partners and internal/external audit teams including regulatory agencies. Assists in developing and implementing departmental strategy and plans that are aligned with the broader organizational strategy. Anticipates risk and builds contingencies to help mitigate impact. Responsible for selection training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities. Ensures the right people and resources are in place and optimally allocated to achieve results. Creates an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing. Builds and develops a diverse, high performing team. Works across functions to build organization and individual capabilities. Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance. Basic Qualifications Doctorate degree OR Master's degree and 3 years of Manufacturing and Operations experience OR Bachelor's degree and 5 years of Manufacturing and Operations experience OR Associate's degree and 10 years of Manufacturing and Operations experience OR High school diploma / GED and 12 years of Manufacturing and Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelor's degree in Life Sciences or Engineering Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing Strong leadership and teambuilding skills (coaching, mentoring, counseling) Experience with staff capability and team performance improvements Experience with performance management including performance reviews Conflict Resolution skills Analytical problem-solving skills Project Management skills Thorough understanding of regulatory requirements Ability to be flexible and manage change Excellent verbal and written communication (technical) skills Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems. 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. PI116260309

Amgen Job ID: R-89716 Location: Thousand Oaks, CA, US 91360 Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Under minimal supervision, an Associate Manufacturing will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving aseptic filling, primarily operation of automated fill equipment inside the aseptic environment. Operation of the fill/stoppering equipment to dispense sterile product into glass or plastic containers Environmental monitoring of the aseptic environment during each fill and after each fill Operation of the continuous particulate monitoring systems during each fill Perform operations during fills by following proper procedures High levels of housekeeping to conform to cGMP standards Detailed and accurate documentation in batch production records Determine availability of components and assign accordingly Position may assist in training of co-workers Perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques Position will perform non-standard shifts, evenings and/or weekends. Revise/Modify GMP documentation including batch records and/or SOPs Basic Qualifications Associate's degree & 4 years of cGMP manufacturing or directly related experience OR High school diploma / GED & 6 years of cGMP manufacturing or directly related experience Preferred Qualifications Bachelors Degree in Mechanical Engineering, Biomedical engineering, Life Sciences or Technology Exposure to aseptic fill, lyophilization, bio-pharma manufacturing equipment, trouble shooting and moving machinery Light to moderate lifting and carrying of 15-44 lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources Experience in maneuvering a highly dynamic process with multi-variable inputs 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. PI116216952

Amgen Job ID: R-89487 Location: Juncos, PR, US 00777 Are you looking for a challenging new opportunity to test and growth your manufacturing skills? We have an immediate need for an Associate Manufacturing to join AML's 14 Vial Filling Team in a Non Standard Shift. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. The Role The Associate Manufacturing role will support the Drug Product Filling operations according to Standard Operating Procedures (SOPs). Will perform and monitor critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures and SOPs. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. Employee may also have the responsibility of owning Deviations/CAPA's. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment. Specific responsibilities include but are not limited to: Hands-on operations, set-up, clean, sanitize and prepare room and equipment for the Filling Process Perform and monitor critical filling 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 Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records) May work generating/receiving inventory orders May train staff to perform hands-on tasks May act as safety representative May assist with system ownership responsibilities You will Need: Bachelor's degree Beyond that, you will also need: Educational background in Life Sciences or Engineering Availability for Non Standard Shift Experience in biotechnology, pharmaceutical or medical device company Experience in filling operations Understand equipment/processes which leads to greater independent judgment Basic mathematical skills Excellent communication skills Technical writing capability GMP knowledge with ability to interpret & apply Interaction...seek outside resources as needed Understand analytical methods for manufacturing area Specific system/equipment skills Basic project management skills Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too. 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 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. PI116187786

Amgen Job ID: R-89216 Location: Thousand Oaks, CA, US 91360 Summary: Site lead for Contract Manufacturing Organizations (CMOs). Single point of accountability and interface between Amgen and assigned external partners. Responsibilities: Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Lead budget development, monitoring, and reporting; build and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively handle and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change. Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management. Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain agreement for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of experience in a synthetic oral solid dosage manufacturing or synthetic packaging manufacturing environment OR Bachelor's degree and 4 years of experience in a synthetic oral solid dosage manufacturing or synthetic packaging manufacturing environment OR Associate's degree and 10 years of experience in a synthetic oral solid dosage manufacturing or synthetic packaging manufacturing environment OR High school diploma / GED and 12 years of experience in a synthetic oral solid dosage manufacturing or synthetic packaging manufacturing environment Preferred Qualifications: Bachelor's in Business Administration, Engineering, or Science-related field 5+ years of experience in a synthetic oral solid dosage manufacturing and synthetic packaging manufacturing environment 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles 2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products 1+ years of project management experience leading multi-functional and multi-location team 1+ years of experience across ACM or CMQ Ability to travel +/- 20% of time (domestic and international) Preferred Competencies: Demonstrated proficiencies of lower GCF levels. Demonstrated matrix management and influencing skills. Manufacturing and cGMP knowledge / experience. Demonstrated negotiation skills. Operational Excellence proficiency and ability to drive continuous improvement. Financial/budgeting knowledge and business acumen. Proficient project management skills. Problem-solving and critical thinking. Understanding of contractual requirements. Technical writing and multi-level communication skills. Demonstrated ability to lead effectively in collaborative/team environment. Demonstrated ability to take initiative, drive action, and work under minimum supervision. 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. PI116078696

Amgen Job ID: R-88972 Location: West Greenwich, RI, US 02817 The Manufacturing Manager position is within the Purification organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. This position offers the opportunity to collaborate with multiple functions on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, Regulatory Compliance, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility and site. With minimal direction, the manager is responsible for leading on the floor operations and staff in manufacturing. The Manager will be responsible for supervising, coaching, hiring, and development of floor staff. The Front-Line Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts. The Manager will need to effectively direct his/her team and deliver on short and long term Amgen Operational goals and will work closely with a second area FLM to manage the operations for the day. Scope of Responsibility Demonstrate technical mastery of purification processes Ensure safe working environment. Ensure cGMP and CFR compliance of operating areas. Resolve problems during operation. Elevate critical and impactful events to Sr. management and make real time processing decisions. Participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor. Develop, implement and assess solutions for complex problems. Ensure scheduling of production and maintenance activities. Collaborate with cross-functional teams (i.e. QA/QC, F&E, PD, Regulatory, etc.) in completing production activities and ensuring schedule adherence. Interact with business partners and internal/external audit teams including regulatory agencies as directed Ensure effective decision-making and clear and timely communication Leading Strategy Development and Execution Assists in developing and implementing departmental strategy and plans that are aligned with the broader organizational strategy Anticipates risk and builds contingencies to help mitigate impact Deliver strong business results Building a Strong Organizational Alignment Responsible for selection training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities. Ensures the right people and resources are in place and optimally allocated to achieve results Creates an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing Builds and develops a diverse, high performing team Works across functions to build organization and individual capabilities Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance Day Shift: (7:00am - 7:00pm rotating days) Basic Qualifications Doctorate degree OR Master's degree and 3 years of Manufacturing and Operations experience OR Bachelor's degree and 5 years of Manufacturing and Operations experience OR Associate's degree and 10 years of Manufacturing and Operations experience OR High school diploma / GED and 12 years of Manufacturing and Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelor's degree in Life Sciences or Engineering Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing Strong leadership and teambuilding skills (coaching, mentoring, counseling) Experience with staff capability and team performance improvements Experience with performance management including performance reviews Conflict Resolution skills Analytical problem solving skills Project Management skills Thorough understanding of regulatory requirements Ability to be flexible and manage change Excellent verbal and written communication (technical) skills Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems. 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. PI115859402

Amgen Job ID: R-83119_1 Location: Thousand Oaks, CA, US 91360 This Specialist Manufacturing position will support the drug substance manufacturing operations in Thousand Oaks, CA. This role requires an experienced and well qualified individual to focus primarily on Quality Systems record ownership (Change Control, deviation, CAPA), in addition to managing projects. This individual will play a key role in managing multiple Change Records with varying complexity. Also the staff member will be leading the investigation of nonconforming events related to the manufacturing operations. The candidate will lead root cause analysis, definition of event scope and lot-tying strategy, assessment of product impact and development and coordination of corrective actions to prevent recurrence. The role may also require management of document revisions, as necessary. Under general direction, assume primary responsibility for execution of the Change Control/deviation/CAPA process in manufacturing. The job will also require trending of nonconforming events to identify systemic issues that need improvement, and tracking and reporting key quality systems metrics to management. Apply process, operational, scientific expertise, compliance knowledge, analytical and troubleshooting skills to support manufacturing operations. Candidates should have good project management skills. Job Scope and responsibilities: Assume ownership of critical Change Record, and nonconforming event investigations within Amgen's Quality Management System (Change Control/ Deviation /CAPA) using the Trackwise database. Represent the manufacturing support team internally within the plant and externally at the site level. Serve as department subject matter expert for the Change Control/ deviation/CAPA process, including metrics reporting and trending. Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, various governance meetings, and management review. Ensure good progress, participation, communication and timely outcomes through cross functional team members who support MFG Apply scientific reasoning and troubleshooting techniques to solve complex process, compliance, and analytical problems in order to ensure MFG production success. This may include support of any of the following; process improvements, operational excellence initiatives, project management, and new product introductions Will work with other functions (Quality, Engineering, Automation, Facilities, Environmental Health & Safety, Process Development, etc.) in troubleshooting nonconforming events, conducting problem solving and RCAs, owning major deviations, complex change records, and developing CAPAs to prevent recurrence. Collaborate with Regulatory and Quality partners to manage records and respond to regulatory questions and/or audit findings. Basic Qualifications: Doctorate degree OR Master's degree & 3 years of manufacturing and operations experience OR Bachelor's degree & 5 years of manufacturing and operations experience OR Associate's degree & 10 years of manufacturing and operations experience OR High school diploma / GED & 12 years of manufacturing and operations experience Preferred Qualifications: Advanced Degree in Engineering or Life Sciences Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development. Technical knowledge of drug substance processing and broad understanding of related disciplinary areas Demonstrated project management abilities Experience in contamination investigations, recovery, and prevention including aseptic technique and clean room behavior. Ability to organize, analyze, and interprets technical data through trend analysis. Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Significant experience with Quality Systems Record ownership Ability to drive results through leadership of cross-functional teams. 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. 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. PI115544773