243 jobs found in thousand oaks

Amgen Job ID: R-87914 Location: Thousand Oaks, CA, US 91360 The Associate of 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 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. PI115671560

Amgen Job ID: R-88406 Location: Thousand Oaks, CA, US 91360 Additional Location: United Kingdom - Uxbridge Amgen is seeking a Pharmacovigilance Operations Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: Under the direction of leadership the Pharmacovigilance Operations Manager will work on projects and process that ensures the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements Provides knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Key Activities: •Participates in the creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents •Supports the department by being a liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs •Support activities to ensure PV Operations input to commercial initiatives •Accountable for reconciliation activities between Global Patient Safety and commercial programs to ensure reporting of all adverse event data •Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication •Develops and communicates plans/objectives to others as needed •Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods •Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety •Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable •Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness •Provide input to GRAAS contracting groups globally •Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility •Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Knowledge and Skills: •Able to effectively represent ideas both verbally and in writing •Sound knowledge of the global safety environment, regulations and guidance •Project and/or Process Management experience & knowledge •Sound understanding of safety data capture, representation and interpretation •Sound knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery •Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally •Able to organize, plan and prioritize workload for the function Basic Qualifications: Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources 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. Amgen focuses on areas of high unmet medical needs 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. PI115671335

Amgen Job ID: R-81535 Location: Thousand Oaks, CA, US 91360 The R&D Learning Operations team, within the R&D Quality, Compliance, Audit, Learning and Performance (QCAL&P) organization, provides expert support for the creation and management of R&D role-based curricula. The team is responsible for ensuring training assignments for R&D staff are appropriately allocated and in line with role-based training requirements. The Learning Operations team also provides R&D oversight and input into Learning Management System (LMS) activities and capabilities, including enhancements and improvements. The newly created Manager, Learning Operations will play a key role for the efficient and effective management of R&D processes related to staff learning and performance. The manager will contribute to implementing strategies, provide leadership to ensure excellence in learning operations solutions and ensure compliance with Amgen and Learning & Performance policies and procedures. The Manager, Learning Operations will be an integral member in working globally with QCAL&P team and management and business process owners to ensure compliance with functional, organizational and departmental training requirements. The Manager, Learning Operations is responsible for the development, maintenance, oversight and continuous improvement of efficient, effective and compliant processes supporting Global Learning and Performance (L&P) R&D Operations through: Serving as the Role-based Curricula (RBC) Business Process Owner which includes management process and administration. Learning Management System course activation, training assignment, reporting and issue resolution. Training material repository maintenance and management. R&D staff training metrics and reporting. Managing L&P SharePoint sites. Initiating requests for proposals, evaluating SoW and supporting vendor contracting (including CARFs). Supporting inspection and audit operations. Developing and executing project plans following a PM life-cycle methodology and developing / utilizing tools for project management, stakeholder and project communication and decision making. Representing interests of R&D L&P on workstreams, project teams and committees along with assessing the impact of initiatives on L&P operations and processes. Partnering with business stakeholders to drive successful implementation of agreed measures. Hiring, managing, developing, retaining, coaching and mentoring staff including setting individual and team goals and conducting performance reviews. Basic Qualifications Doctorate degree OR Master's degree and 3 years of related learning/training experience OR Bachelor's degree and 5 years of related learning/training experience OR Associate's degree and 10 years of related learning/training experience OR High school diploma / GED and 12 years of related learning/training experience Preferred Qualifications Advanced degree related to training and development or similar discipline Eight or more years experience in learning and performance or other training-related areas Three or more years experience leading projects and programs related to systems, processes and continuous improvement Experience in staff management and development Demonstrated ability to execute against goals and strategy and operate in a complex global, cross-functional, matrixed environment R&D work experience at a biotech, pharmaceutical or CRO company that includes knowledge of applicable regulations and learning and performance processes Proven background in internal and external stakeholder management and strategic partnerships Being up to date with learning and performance trends and best practices 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. PI115671354

Amgen Job ID: R-88292 Location: Thousand Oaks, CA, US 91360 The Executive Director, Global Oncology Portfolio Innovation & Commercial Operations is responsible for three different critical oncology areas which are key for the business of the function and Global Product Strategy & Commercial Innovation (GPS&CI) in the future. These areas are Congresses and Meetings, Patient Support Programs and Marketing Operations. The position will support, Oncology and reports to the VP Solid Tumors and will have indirect reporting line to VP Hematology. The position requires internal cross functional and key stakeholder alignment as well as external stakeholder management. Responsibilities: Congress and Meetings - Oversee strategy for portfolio Congress Management across all functions to ensure alignment and "One Amgen Voice" Lead strategic initiatives to establish a new model for better Oncology resource management internally while positioning Amgen at the right place externally Manage relationships with external stakeholders (e.g. exhibits & Societies) Act as an interface to Global Meetings Management (Finance) Oversee strategy for Oncology advisory Board meetings including alignment across teams and Product Teams Define Global Opinion Leaders Coordination and implement new process Have full visibility and responsibility for Oncology congress budget management which is over $10M Patient Support Program - Establish a global strategy for Patient Support Programs in Oncology Ensure global connectivity across Regions Build capabilities in the team including updated but simplified processes per SOP's (Standard Operating Procedures) tools, unbranded materials Operate as commercial point of contact for inspections and audits, and escalation point for process decisions Serve as ultimate decision-maker on process changes, including updates to site content, controlled documents, and associated training materials Operate in close partnership with, and commercial point of contact for the business and cross-functional stakeholders (i.e., Safety/Quality/Compliance) for Oncology Identify/ guide implementation related to innovations in Oncology Responsible for vendor management (where applicable) Marketing Operations - Serve as advisor on agency management and leverage best practice sharing (Global relationship, best practices) Work closely with production management (Global relationship) With expertise, initiate, design and supervise execution of Portfolio, CRM platforms, Multi-channel marketing, Digital platforms Create go-to-market model "one team model", (FSC) Franchise Steering Committee disease area alignment coordination and global communications Basic Qualifications: Doctorate degree and 6 years of commercial experience OR Master's degree and 10 years of commercial experience OR Bachelor's degree and 12 years of commercial experience AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Advocacy and communication skills Strategic thinking, analytical and project management skills Goal oriented and results driven Ability to lead and manage projects from concept to completion Quick learner, proactive, takes initiative Interpersonal skills, negotiation skills, active listening, and relationship management skills Interface effectively with all levels, including senior management Influence others while fostering a value-based environment of high performance and fairness Understand, plan, and navigate in a matrix and, at times, ambiguous environment Verbal and written communication skills with ability to clearly and effectively present information Demonstrates creativity and foresight in anticipating and solving complex project issues Awareness and ability to navigate and conform to Commercialization and Corporate Governance 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. PI115671408

Amgen Job ID: R-87694 Location: Thousand Oaks, CA, US 91360 Job Summary Amgen is currently seeking a Associate Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for pivotal phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The Associate Scientist will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. Small Molecule Attribute Sciences Key Responsibilities: A largely laboratory-based position where focus will be on driving cutting-edge analytical support and technology development impacting process and product development teams across Amgen's portfolio Work cross-functionally and across R&D sites while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline Basic Qualifications: Master's degree and 2 years of Scientific experience OR Bachelor's degree and 4 years of Scientific experience Preferred Qualifications : Master's degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering Training and expertise in analytical method development and organic chemistry or formulation development Demonstrated ability to analyze and interpret analytical data 3+ year's in the pharmaceutical or biotech industry Strong understanding, research in, and hands-on experience with chromatographic techniques, such as Liquid chromatography and gas chromatography, as applied to pharmaceutical development Strong understanding, research in, and hands on experience with dissolution techniques for solid oral dosage forms. Strong technical aptitude for the identification, development, and implementation of novel analytical technologies, such as Mass spectrometry (MS), NMR, Vibrational spectroscopy etc Structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry Familiarity with automation and implementing data management systems; ability to compile and communicate complex datasets in a manner in which facilitates informed decision-making Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment Strong abilities in trouble-shooting, problem solving, and multi-tasking in support of process chemistry and formulation efforts at the pivotal phase of development 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. PI115671427

Amgen Job ID: R-87693 Location: Thousand Oaks, CA, US 91360 Job Description Amgen is currently seeking a Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for pivotal phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The Scientist will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application. Key Responsibilities: Identifying and characterizing attributes of therapeutic synthetic molecules Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs. Develop and apply novel sample preparation and analytical methods for analysis of therapeutic synthetic molecules with emphasis on chromatography and mass spectrometry (LC-MS/MS) Collaborate closely with drug substance and drug product process development colleagues. Manage activities at contract manufacturing and testing sites. May lead and develop a small group of scientists. Basic Qualifications: Doctorate degree OR Master's degree and 4 years of scientific experience OR Bachelor's degree and 6 years of scientific experience Preferred Qualifications: •PhD in Analytical Chemistry or Biochemistry with emphasis in mass spectrometry •2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development. •Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry. •Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc. •Developing and implementing methods for in-process testing, release and stability testing. •Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products. •Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc. •Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner •Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines •Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile •Works well in cross-functional teams, and across various geographic locations in different time zones •Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents 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. PI115671446

Amgen Job ID: R-87648 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Global Safety Physician at its main headquarters in Thousand Oaks, CA to join the GPS-TAS (Global Patient Safety - Therapeutic Areas) organization and will serve as the medical expert for the team to support the Global Safety Officer in the management of safety signal, risk management activities, and benefit risk assessments for an assigned set of products. The Global Safety Physician will report to either a Global Safety Officer (GSO) or the Executive Medical Director Global Patient Safety and will be responsible for the conduct of safety monitoring and accountable for executing product related safety decisions and deliverables for assigned products as designated by GSO or TAH (therapeutic area head). The Global Safety Officer may delegate to the Global Safety Physician. Remote locations from Thousand Oaks may be considered. The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product from early clinical development to marketed products. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The Global Safety Physician is responsible for the following: Directs the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison activities with affiliates and other internal Amgen partners regarding products Supports and provides oversight with regards to safety in clinical trials to Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies. Support activities related to new drug applications and other regulatory filings Perform Signal detection, evaluation, and management Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and Pharmacovigilance scientist Prepare presentations to the Global Safety Team on safety issues Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities Additional duties as assigned Basic Qualifications MD or equivalent degree from an accredited medical school Preferred Qualifications Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Clinical/medical research experience Product safety in the bio/pharmaceutical industry Experience in Inflammation and N ephrology, Cardiovascular, Bone or Oncology 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. 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. PI115671465

Amgen Job ID: R-87853 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Puerto Rico - Juncos, US - Florida - Tampa, US - Rhode Island - West Greenwich Amgen is seeking a Quality Assurance Sr. Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: The QA Sr Manager role is responsible for Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. This position is responsible for being an integral quality member of Amgen cross-functional Supplier Quality team that includes but is not limited to business operations, analytical science, process development, supply chain. Additional Duties Include: Execute Amgen Supplier audits Negotiator and Approver of quality agreements Lead the preparation of the site for and represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas Quality approver for deviations, change controls, CAPA Prepare inspection playbooks Identify and mitigate Risk at the Supplier, CMO and/or testing Laboratories and/or escalate to management Manage Audit commitments to completion Basic Qualifications Doctorate degree and 2 years of Quality or Manufacturing or Operations experience OR Master's degree and 4 years of Quality or Manufacturing or Operations experience OR Bachelor's degree and 6 years of Quality or Manufacturing or Operations experience OR Associate's degree and 10 years of Quality or Manufacturing or Operations experience OR High school diploma / GED and 12 years of Quality or Manufacturing or Operations experience Preferred Qualifications Ideally 8 plus years biotech or pharmaceutical industry experience Auditor Certification or experience performing audits Raw Material Compendial Testing proficiency Knowledge of Single Use Systems, Resins, and filters in an aseptic manufacturing facility Additional European Languages Significant Quality experience at Aseptic Manufacturing facilities Able to facilitate and influence senior stakeholders and partners Able to successfully manage workload and 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 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 Experience driving decision making by using DAI principles Experience with the "variation management" process 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. Amgen focuses on areas of high unmet medical needs 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. PI115671202

Amgen Job ID: R-88501 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. Our Repatha® team is passionate about seizing the unique opportunity to bring the promise of biotechnology to millions of cardiovascular patients to make a difference in their lives. The US Marketing Senior Manager, Cardiovascular will support the development and execution of a wide range of strategic and promotional tactics and activities focusing on Repatha. The Senior Manager will oversee the execution of both personal and non-personal promotional programs and tactics targeted to Cardiology audiences that highlight the impact and consequences of cardiovascular disease and the potential clinical benefits of a new CV therapeutic in helping patients who have not achieved clinical goals on standard of care. This is an excellent opportunity for an experienced marketer or cardiovascular expert seeking to join a high performing team committed to driving growth of a potential multi-billion dollar cardiology franchise. Responsibilities include: Developing strategy, tactics and critical success factors Developing promotional campaigns, messages, programs and sales tools Coordinating the work of multiple external vendors and internal departments including marketing, market research, legal, regulatory, medical affairs, segment marketing, corporate compliance, consumer marketing and IS Leading projects through the legal, regulatory, and medical review process Managing program budgets and developing metrics to ensure success of the promotional programs Helping to guide strategic decisions and ensuring flawless execution of promotional campaigns and programs for Cardiology Engage often with the Opinion Leaders and the global marketing team to ensure creation and flawless roll out of high impact, high value marketing tools that lay the foundation for launch Collaborate with sales training to ensure effective, impactful, world class training on promotional tools and programs Coordinates and drives market research planning Basic Qualifications Doctorate degree and 2 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Master's degree and 4 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Bachelor's degree and 6 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR Associate's Degree and 10 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization OR High school diploma / GED and 12 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization Preferred Qualifications MBA in marketing, healthcare management, or related discipline 2+ years of experience in developing, executing, and measuring marketing campaigns for specialty products or significant experience promoting statins Demonstrated track record of increasing responsibility within sales and marketing Experience in Cardiology or other specialty markets (clinical acumen is key to the success of this role) Demonstrated analytical skills and the ability to think strategically and solve problems Proven ability to collaborate and work cross-functionally to drive business results in a heavily matrixed, fast-paced environment Strong leadership and ability to drive influence across stakeholders to set direction, align work efforts, and ensure flawless execution Experience working closely with field sales organizations to implement marketing programs with measurable business impact Outstanding project management skills and experience managing multiple vendors and agency partners Ability to effectively manage multiple competing priorities Strong understanding of legal and regulatory environment in pharmaceutical promotions, pharma industry guidelines, and other compliance-related issues Excellent verbal and written communication skills Experience developing and executing clinical marketing programs 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. PI115671221

Amgen Job ID: R-88066 Location: Thousand Oaks, CA, US 91360 Additional Location: US - Puerto Rico - Juncos, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge, US - California - South San Francisco Environment and Sustainability Manager position works in the Environment Health Safety and Sustainability organization, reporting to the Director of Environment and Sustainability. The EHSS Manager role will support the development and execution of a broad-based, company-wide strategic environmental compliance and environmental sustainability initiatives, integrating environmental compliance and environmental sustainability throughout the company. You will ensure that the company's environment efforts enhance business performance and supports the long-term interests of the company. Candidate must be an innovative thinker who can constructively challenge conventional ways of thinking and introduce new ideas. This includes: Develop the business case and execute environmental compliance and environmental sustainability initiatives. Oversee program measurement, including ability to build reputation and create business value. Collaborate with the company's internal functions to develop a coordinated environment plan. Secure and leverage senior level commitment and support for integrating sustainable development into core processes and decision-making. Execute employee-engaging environmental sustainability programs that builds Amgen's reputation as a company of choice. Drive Amgen's overarching environment short- and long-range view; including policy, procedures, governance, performance measurements, evaluation and reporting. Assess current and emerging global environment issues. Create and implement communication strategies to publicize the company's environmental sustainability effort and promote broad awareness of environment initiatives, both internally and externally. Measure and monitor progress against strategies, objectives and performance targets. Basic Qualifications Doctorate degree OR Master's degree and 3 years of Environmental Compliance and/or Sustainability experience OR Bachelor's degree and 5 years of Environmental Compliance and/or Sustainability experience OR Associate's degree and 10 years of Environmental Compliance and/or Sustainability experience OR High school diploma / GED and 12 years of Environmental Compliance and/or Sustainability experience Preferred Qualifications Excellent communication skills: written, verbal and presentation skills Strong problem solving and analysis skills Strong teamwork and interpersonal skills Ability to interact in a professional manner with customers Knowledge of key sustainability initiatives such as the United Nation Sustainable Development Goals, Circular Economy, Science Based Targets, Greenhouse Gas inventory Exhibits sound judgment and professionalism in all aspects of the position Able to differentiate between conflicting priorities and issues to identify underlying causes Demonstrated ability to manage multiple tasks and assess priorities effectively Works closely managing directors, plant managers, facility directors, Sales and Marketing personnel, engineering and EH&S personnel Consistently exhibits company values in all interactions with associates and customers 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. PI115671259

Amgen Job ID: R-82291 Location: Thousand Oaks, CA, US 91360 Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods and container closure integrity test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability. RESPONSIBILITIES: Assure transfer of new combination product test methods or container closure integrity methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation. Implement projects per FPT (Final Product Technologies) and company procedures to ensure projects are completed on schedule and within established budget. Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes. Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving). Coordinate gauge and equipment development and delivery with selected contractors. Ensure that qualification parameters are met for product assembly and performance requirements. Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation. Generate procedures necessary to support department and new product equipment. Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers). Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system. Excellent communication (written and verbal) and organizational skills Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverablesand impacts to risk. Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently Integrates partner/vendor timelines with Amgen timelines as appropriate The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes. Basic Qualifications: Doctorate degree OR Master's degree and 3 years ofengineering 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: Masters in Mechanical, Biomedical Engineering or Materials Science 6 + years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry Excellent written and verbal communication skills together with demonstrated ability to work in a team environment Proven track record of project management and leading cross-functional projects Ability to coach junior engineers Strong team work, excellent interpersonal and communication 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. 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. PI115671278

Amgen Job ID: R-81431 Location: Thousand Oaks, CA, US 91360 The Value & Access Director -- Patient-Centered Outcomes (PCO) will be responsible for supporting product teams (PTs) in the development and implementation of patient-reported outcome (PRO), clinical outcome assessment (COA) and other patient-centered measurement strategies. The Director will facilitate the inclusion of patient insights into the clinical development program, contributing PCO strategies and expertise to support access of our therapeutics to patients. The Director will engage with cross-functional teams and key stakeholders to partner in the incorporation of the PCO strategy within the evidence generation plan. The role provides PCO strategy development and execution expertise during clinical trials at study level, program level and across therapeutic areas. In addition, the Director will build and expand their professional network, acting as a representative for PCO research within Amgen and externally with patients, clinicians, regulatory bodies and payers. Key accountabilities include: Development of PCO therapeutic-area and product-level strategic options for presentation to Franchise Steering Committee (FSC) and PT Incorporating patient-focused outcomes throughout drug development by driving development and execution of sound PRO strategies and methodologies Ensuring rigor and expertise is applied to PCO decision-making on analyses related to: PRO strategy, PRO development and validation, psychometrics, ePRO integration and PRO translations Working with the GHE Product Lead (GHE PL) on embedding the PCO strategy into the evidence generation plan as part of the overall value-evidence generation strategy Development of materials to support and engaging in regulatory interactions on PCOs (e.g. regulatory briefings, etc.) Driving initiatives to capture, share and incorporate PCO best practices and regulatory guidance across the organization Developing and enforcing PCO SOPs and guidance w/Team Head Basic Qualifications: Doctorate degree and 4 years of health economics and/or outcomes research and/or market access and/or market research experience OR Master's degree and 7years of health economics and/or outcomes research and/or market access and/or market research experience OR Bachelor's degree and 9 years of health economics and/or outcomes research and/or market access and/or market research experience Preferred Qualifications: Graduate degree in health economics and/or epidemiologic statistical and analytical methodologies 6+ years of industry experience in the Biotechnology, Pharmaceutical, or other Healthcare related field 5+ years of experience in Health Outcomes role, specializing in patient-reported outcomes Experience in the development and validation of PROs, such as utilizing regulatory guidance to develop a conceptual framework, performing qualitative research, creating a de novo PRO, validating PROs using CDIs, and/or performing psychometrics for quantitative validation Patient experience market research Broad therapeutic area expertise Experience incorporating PROs into a pre-commercial study Experience supporting and leading regulatory interactions related to PROs Experience supporting and leading advocacy and special-interest group activities Very passionate about patient-centric drug development and patient-centricity Ability to influence with and without authority Understands and navigates a matrixed and, at times, ambiguous environment Strong verbal and written communication skills Strong clinical, health economics, and commercial acumen and instincts Understanding of a range of market, policy, social, and economic influences and trends that may impact drug development and commercialization Demonstrated creativity in addressing strategic challenges; thinks outside-the-box; asks the right questions; seeks expert opinions and insights; applies innovative ideas and takes measured risks Ability to develop and articulate a strong value proposition Works effectively in a team-based organization, collaborates cross functionally, builds alignment around key objectives and exercises influence at all levels Ability to build consensus and achieve agreement on key priorities Understanding of healthcare ecosystems, patient, payer, HTA and HCP decision-making, and value drivers for each of those stakeholders across global markets Understanding of key industry, policy and market trends impacting patients and all PCO-related developments Understanding of how different trial designs and outcomes may influence clinical guidelines, market access and reimbursement Understanding of the evidentiary requirements and decision-making process of HTA agencies related to PROs Significant understanding of regulatory policy issues relating to PROs, HTA decision-making, drug value and reimbursement across the major global healthcare markets Skilled at influence and persuasion: able to convince others to act on information or recommendations based on compelling logic or common best interests 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. PI115671297

394 N. Moorpark Road, Thousand Oaks, CA 91360 USA Seasonal Team Member Cashier | Stock | Sales Assistant ABOUT THE ROLE As a Seasonal Team Member, you play an essential role in the customer service experience by providing customers with fast and friendly service during our busy holiday season. You will build relationships with customers, process transactions, maintain floor merchandise and inventory standards, answer questions, and ensure customers leave feeling positive about their visit. Both part-time and full-time positions may rotate between working as a cashier, a sales specialist or merchandiser/stock associate. You will report to the store management team. Join us to work in one of the most fun and thriving retail companies around! You will Provide customer service by greeting and establishing a relationship with customers while informing them of our products and services. Perform cashier functions and follow minor policy while completing customer transactions Share Total Wine & More's product portfolio Assist with stocking and maintaining inventory levels; communicate any inventory issues/concerns to leadership Maintain store safety and cleanliness standards on the sales floor, stock room, lockers, kitchen, bathroom, etc. Collection of carts from parking lot and assisting customers with loading purchases in their vehicles Receive great employee discounts! What we're looking for 21 years of age or older Ability to work a flexible schedule as business requires, which may also depend on your preference for part-time or full-time hours Experience using technology applicable to the position and access information necessary to complete daily responsibilities Strong interpersonal skills with a positive and engaging attitude Value collaboration and acting as a team player Physical Requirements (with or without accommodations): Walk, bend down repeatedly, and be on feet for 8-10 hours a day Climb ladders and lift 50 lbs. overhead and repeatedly Total Wine & More is the country's largest independent retailer of fine wine, beer and spirits, and we continue to grow our footprint year over year. Total Wine offers exciting and unique career opportunities across the country and in our corporate office. Our strength is our people. We have a commitment to training and career growth, all in an environment that values new ideas and teamwork. If you share our entrepreneurial spirit and a passion for providing best-in-class customer experience, take a moment to apply or learn more at www.TotalWine.com/About-us/Careers ! Total Wine & More is an equal opportunity employer and all qualified applicants will receive consideration for employment without discrimination based on race, color, religion, national origin, sex, sexual orientation, age, marital status, veteran status, disability, or any other characteristic protected by applicable law. Total Wine & More makes reasonable accommodations during all aspects of the employment process, including during the interview process. Total Wine & More is a Drug Free Workplace. The information provided above indicates the general nature and level of work required of the position and is not a comprehensive list of all responsibilities or qualifications. Benefits list is only a highlight of some of the benefits offered to team members; eligibility for certain benefits apply. ; PI115622610

Are you looking for meaningful work? Are you passionate about making a difference? If so, then UCPLA is the company for you. When you join UCPLA, you will help us promote independence for adults with developmental and intellectual disabilities. We offer competitive starting salaries and benefits to full-time staff: Health, Dental, Vision, and Life Insurance, Life Assistance Program, Flexible Spending Account (FSA), Paid Holidays, Vacation Benefits, Paid Sick Leave, Paid Bereavement Leave, Credit Union Benefits and Discounts, Referral Bonus Plan, and Retirement Plan. United Cerebral Palsy of Los Angeles, Ventura & Santa Barbara Counties (UCPLA) is currently hiring a Lead Direct Support Professional (LDSP) to assist developmentally disabled individuals with daily living needs in a group home residential setting. LDSPs provide guidance and assistance to Direct Support Professionals regarding proper care assistance techniques. Under direct supervision of highly qualified professionals, LDSPs monitor and support our clients' needs, both physically and emotionally. LDSPs have the unique opportunity to build a rewarding career in healthcare and develop caring relationships with our clients. Rate of Pay: $14.75 per hour Schedule: Five (5) Days per work week, 2:30 PM - 11:00 PM Must be available to work one (1) weekend shift per work week Responsibilities: Delegate tasks to Direct Support Professionals Assist residents with moving in and out of beds, baths, wheelchairs, and automobiles, and with eating, dressing, and grooming. Respect and promote the individual rights of people served Provide direct care and other related duties as assigned by supervisor(s) and/or nursing staff Attend required in-service trainings Other duties as assigned Qualifications: Must be at least 18 years of age Read, write, comprehend, and communicate in English well enough to perform essential duties and responsibilities Ability to maintain confidentiality Communicate and work professionally and cooperatively with others Successfully pass all post-offer, pre-employment screening requirements, including criminal background check, drug screening, and provide proof of eligibility to work in the United States Ability to run, push, pull, bend, squat, kneel, and lift up to fifty (50) pounds Leadership experience desired for this role Med Techs are encouraged to apply! With 40 programs and service sites spanning several counties, UCPLA is the largest nonprofit provider of direct care services for individuals with developmental and intellectual disabilities in Southern California. UCPLA is an equal opportunity employer and is required to comply with equal opportunity legislation in each jurisdiction in which it operates. UCPLA also considers qualified applicants with criminal histories for employment pursuant to California Law and, if applicable, the L.A. Fair Chance Ordinance. PM17 PI115614550

Amgen Job ID: R-87073 Location: Thousand Oaks, CA, US 91360 In the context of the rapidly evolving healthcare environment with increased focus on the cost and affordability of innovative new specialty medicines, Amgen is committed to developing a new capability to develop and execute global strategies to establish and sustain value-based partnerships with healthcare payers, governments and delivery systems. The US Value Based Partnerships (VBP) will enable innovative mechanisms of patient access that create win-win-win situations for patients, payers and Amgen, while improving access to key stakeholders and their support of policies that shape the external environment. The US Value Based Partnership team will lead complex, cross-therapeutic area partnerships, and will also be tasked with providing strategic and project management support to the US partnerships. The Senior Manager will be responsible for understanding market needs that align with Amgen's strategic priorities and lead to better patient csare. The successful candidate will be responsible for leading a diverse cross functional team to ideate, prioritize, manage, and timely execute collaborative projects with strategic external partners on a day to day basis. He/she will interface with Amgen's Organized Customer Account Team (OCT) and VBP Field Leads in the management of ongoing collaborations. He/she will also act as point/advisor on market research related value based partnerships. The Senior Manager will: Lead cross functional team (including Reimbursement Access & Value (RAV), Brand, Global Health Economics (GHE), Centers for Observational Research (CfOR), Medical, OCT, and Digital Health) to define and execute high value projects with external partners. Collaborate with Legal, Regulatory and Safety partners to assure that potential projects comply with Amgen's policies and adhere to all legal and safety requirements. Lead meetings with external partners to manage projects and ensure that they stay on timelines. Evaluate and disseminate project results to internal and external stakeholders. Draft project scopes between Amgen and partners (commercial payers, Integrated Delivery Networks, Accountable Care Organizations, and Independent Physician Associations) Collaborate with internal stakeholders to ensure the availability of funds for current and future projects. Manage the activities of vendors as needed to create and deploy field resources and support work on VBPs. Manage project budgets and assure timely payment for deliverables. Travel: domestic - approximately 10% Basic Qualifications Doctorate degree and 2 years of project management experience OR Master's degree and 4 years of project management experience OR Bachelor's degree or and 6 years of project management experience OR Associate's degree and 10 years of project management experience OR High school diploma / GED and 12 years of project management experience Preferred Qualifications Bachelor's degree Project management experience in the biopharma industry, with significant interaction with external customers Strong understanding of the US health care system and health economics/outcomes, including coverage and reimbursement, pricing, value drivers, and formulary management. Experience managing 3rd party vendors, including creation of scope of work documents and project oversight. Experience leading cross functional teams, including customer teams Experience in Market Research or understanding of qualitative and quantitative market research Experience working in matrixed environment. Experience in roles covering different therapeutic areas Demonstrated ability to be creative and think outside the box; a strong strategic thinker. Amgen is committed to unlocking the potential 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. 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. At Amgen, contributions are recognized - and strong performance is rewarded. Regularly recognized as a "Best Place to Work," we enable staff to chart their own career paths based on their unique talents by offering challenging assignments, active career development, coaching and individual rewards. #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. PI115634968

Amgen Job ID: R-88405 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Pharmacovigilance Operations Sr Mgr . to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: This role is accountable for the development of Pharmacovigilance Operations strategy for safety-related organized data collection in Amgen clinical trials and commercial activities (e.g. patient support programs and market research) in compliance with global regulatory requirements and Amgen compliance policies and standards. Accountable for the review, approval and execution of PV Operations safety data collection strategy across clinical trial and commercial programs. Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs for all Amgen products. Duties Include: •Ensure the strategies of the department are executed into the safety related organized data collection activities in Amgen clinical trials and commercial activities to ensure Amgen remains compliant with global safety legislation and requirements •Provide expert knowledge into Clinical and Commercial teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies and commercial activities/programs that may generate adverse event data •Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs and activities •Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness •Be point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Key Activities: •Accountable for ensuring creation and dissemination of appropriate safety reporting language in commercial and clinical trial key documents •Accountable as liaison between clinical trial and commercial programs (patient support and market research) and Global Patient Safety to ensure capture of all adverse event data generated by such programs •Initiate and support activities to ensure PV Operations input to commercial initiatives •Accountable for reconciliation activities between Global Patient Safety and commercial programs to ensure reporting of all adverse event data •Responsible for developing and supporting strong cross-functional relationships and communication •Develop and communicate plans/objectives to others as needed •Maintain knowledge of adverse event collection and reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods •Lead the implementation of new processes and methods within and across Global Patient Safety •Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable •Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness •Provide input to GRAAS contracting groups globally •Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility •Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Knowledge and Skills: •Able to effectively represent ideas both verbally and in writing •Expert knowledge of the global safety environment, regulations and guidance •Project and/or Process Management experience & knowledge •Expert understanding of safety data capture, representation and interpretation •Expert knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery •Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally •Able to organize, plan, and prioritize workload for the function Basic Qualifications: • Doctorate degree and 2 years of directly related experience OR • Master's degree and 4 years of directly related experience OR • Bachelor's degree and 6 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources 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. Amgen focuses on areas of high unmet medical needs 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. 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. PI115634987

Amgen Job ID: R-88367 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 successful candidate will be responsible for the development of medical communication resources including but not limited to slide decks, clinical/scientific FAQs, and medical information letters for Amgen's leukemia and lymphoma pipeline and in-line products. The Global Medical Communications (GMC) team is responsible for the creation of high quality and high impact global resources that communicate the science and data on Amgen's portfolio. The GMC team works closely with cross-functional and cross-geographic partners including the Global Medical Affairs Leads, early and Clinical Development to inform and execute medical strategies. Job Summary Monitor and analyze medical insights and inquiries to inform development of scientific and medical resources Drive and/or support strategy and scientific content development for major scientific meetings Drive and/or support strategy and scientific content development for advisory boards Provide scientific support to other Amgen departments Develop disease state resources that educate on topics relevant to the therapeutic area Respond to complex global product-related medical information inquiries (ex-US) Understand global landscape (disease, scientific, regulatory, etc.) and apply expertise to development of scientific resources Analyze medical literature to inform medical strategies and tactics Manage project-associated budgets and vendors Som e trave l ma y b e require d - approximatel y 10-20%. Basic Qualifications Doctorate degree and 2 years of clinical, academic, or industry experience OR Master's degree and 6 years of clinical, academic, or industry experience OR Bachelor's degree and 8 years ofclinical, academic, or industry experience OR Associate's degree and 10 years ofclinical, academic, or industry experience OR High school diploma / GED and 12 years of clinical, academic, or industry experience Preferred Qualifications PharmD, PhD, MD, or DO with 4 or more years of relevant experience in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (Other doctorate degrees may be considered) Prior experience in Medical Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research experience in the areas of Hematology-Oncology An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products Aptitude in writing and presenting on scientific and clinical data Excellent communication (written and verbal), interpersonal, organizational, time management, and project planning skills with strong ability for self-direction Demonstrated track record of strategic execution in a matrix environment with limited supervision The ability to work in teams and interface in a dynamic environment across corporate functions Understanding of disease landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally Prior experience of successfully managing consultants and vendors Strong computer and database skills, particularly with Microsoft Office products Experience with Digital Communications 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. 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. PI115635006

Amgen Job ID: R-88114 Location: Thousand Oaks, CA, US 91360 Amgen is seeking a Statistical Programming Manager to join its Center for Observational Research (CfOR). As a member of the CfOR's Data and Analytic Center, the Manager will support organizational goals by partnering with epidemiologists to develop data strategies and coordinate with functional service providers (FSP) to deliver goal-based results. The Manager will stay informed of evolving department needs and industry best practices and develop innovative, impactful proposals to increase efficiency and support the organization's growth strategies. Specific responsibilities include: Coordinating with functional leads to prioritize and manage workflow and FSP-based statistical programming teams to deliver on time and to specifications. Collaborating with CfOR FSP liaison to ensure performance and quality standards. Ensuring analysis and presentations of biomedical data is accurate and complete. Writing, testing and validating macros, utilities and software programs in Unix to produce analysis datasets and presentations. Reviewing and approving key study-related documents produced from other functions . Representing the programming function and participating in multidisciplinary team meetings. Contributing to the efficiency and continuous and improvements of programming, CfOR, and Research and Development (R&D). Participating in the development and review of CfOR Policies, SOPs and other controlled documents. Participating in studies and system audits by Clinical Quality Assurance (CQA) and external bodies including responding to audit questions and findings. Participating in external professional organizations, conferences and meetings. Mentoring junior programmers and interviewing potential candidates. A remote working arrangement will be considered for this position. Basic Qualifications Doctorate degree OR Master's degree and 3 years of related programming experience OR Bachelor's degree and 5 years of related programming experience OR Associate's degree and 10 years of related programming experience OR High school diploma / GED and 12 years of related programming experience Preferred Qualifications Master's degree in Epidemiology, Biostatistics, Computer Science or other subject with high statistical content At least five years in SAS statistical and database programming using SQL including experience with advanced statistical methods such as survival and regression Vendor or FSP relationship management experience Experience in a regulated environment Training and/or experience using the Observational Medical Outcomes Partnership ( OMOP ) common data model Training and/or experience with the Hadoop database platform, Impala and Hive SQL Pharmaceutical industry experience Experience with real world healthcare data such as MarketScan, Optum, DRG, PharMetrics, Medicare and EMR databases Experience with R, Python or other procedural languages Agile project management methodology experience Working knowledge of computer operating systems including cloud-based (AWS), Databricks and UNIX Proven communication, project management, teamwork and problem-solving abilities with strong attention to details 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. PI115635025

Amgen Job ID: R-88280 Location: Thousand Oaks, CA, US 91360 The Manufacturing Associate position will execute production unit operations and other activities supporting clinical and commercial operations for drug substance manufacturing in stainless steel and single-use equipment. The Manufacturing Associate will monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The Associate Manufacturing may participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and may identify, recommend, and implement improvements related to routine functions. This role will interface between the GMP manufacturing teams in the plant and Quality, Engineering, and other partner organizations. Job scope and responsibilities: Under minimal supervision, performs manufacturing processes according to Standard Operating Procedures. Set-up, clean, and sanitize equipment, and prepare media and buffers per procedures Lead, Perform, and monitor critical processes Comply with cGMP's Analytical testing to support production, including pH, cell counting, protein concentration, etc. Identify and recommend improvements to operations, and implement after approval Basic troubleshooting Recognize & accurately report problems Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) Train new staff to perform hands-on tasks May act as safety representative Ability to be flexible and manage change Basic Qualifications: Bachelor's degree Or Associate's degree and 4 years of biotech or pharmaceutical manufacturing, process development or quality experience Or High School diploma/GED and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience Preferred Qualifications: Bachelor's degree and at least 1 year experience in regulated environment Experience and basic troubleshooting skills with laboratory and process equipment Experience with DeltaV, OSI PI, LIMS, TrackWise Understand, apply and evaluate basic chemistry, biology and physical principles Adhere to regulatory requirements, written procedures and safety guidelines Evaluate documentation/data according to company and regulatory guidelines Interact with inspectors (internal and external) Interpret and apply current Good Manufacturing Practices (cGMP) Demonstrated written and oral communication skills Technical writing capabilities Available for non-standard shifts including nights and weekends. 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. PI115635044

Amgen Job ID: R-88126 Location: Thousand Oaks, CA, US 91360 Additional Location: US - California - San Jose, US - Utah - Salt Lake City, US - California - Santa Monica, US - Texas - Houston, US - Washington - Seattle, US - Colorado - Denver, US - Massachusetts - Cambridge, US - North Carolina - Charlotte, US - New York - New York, US - California - South San Francisco, US - Florida - Tampa, US - Washington D.C. Would you like to take your full stack engineering skills and help deliver the world's most advanced and life-changing biotech medicines by building creative and ground-breaking software frameworks? Amgen is using cloud technology, DevSecOps frameworks, and migration and continuous deployment pipelines to build new drug therapies for patients that address grievous illnesses. We are seeking a Principal Software Development Engineer--Observability and Monitoring to fill a position in Amgen's newly created Cloud Center of Excellence (CCOE) team. Our small product team is a high-energy, tight-knit group who builds our DevSecOps framework used globally by Amgen development teams. This position focuses on innovating and developing our current full stack, open-source monitoring service as well as extending its value to all users of our internally developed DevSecOps framework. Our mission is to meet Amgen's software development needs as well as our DataOps needs for AI and ML data scientists. Our frameworks are built using open-source and AWS services. They manage custom code development, DataOps, as well as test and deploy Commercial-Off-The-Shelf (COTS) applications into Amgen's cloud environment. We are currently extending our capabilities to integrate serverless and microservices CI/CD pipelines with AWS. Job Responsibilities: Be the owner and lead engineer for our end-to-end observability and monitoring service. Develop, refactor, research and improve its capabilities across our cloud security architecture and our continuous CI/CD pipeline. Understand how the instrumentation trade-offs affect the value users get from the service. Provide technical leadership across Amgen to enhance the culture of innovation, automation, and solving difficult scientific and business challenges. Technical leadership includes providing solutions based on DevSecOps, DevOps, and DataOps frameworks with full stack monitoring and observability imbedded into our frameworks. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively. Lead selected efforts to design, build, and develop rapid Proof-of-Concept (POC) solutions and services. Quickly and iteratively prove or disprove the concepts being considered. Evaluate, decide, and implement new open-source software that will enhance our observability tools and scale to meet our global needs Be an integral member of the core DevSecOps/DataOps development team and help develop, test, deploy, and operate the service 24x7x365 globally. Basic Qualifications Doctorate degree and 2 years of related experience Or Master's degree and 4 years' related experience Or Bachelor's degree and 6 years of related experience Or Associate's degree and 10 years of related experience Or High School Diploma / GED and 12 years of related experience Preferred Qualifications BS or MS in computer science or related field 3-5+ years of experience as a full stack software engineer shipping successful commercial products and/or services to customers using a SDLC process from start to finish 3-5 years' experience designing, developing, deploying, and operating observability frameworks using open-source tools such as InfluxDB, Grafana, Telegraf, and FluentD 1-2 years of experience designing, implementing, and operating observability and monitoring services in public cloud environments-AWS preferred Knowledge of instrumenting applications with user analytics frameworks like Matomo and Google Analytics Working knowledge providing OpenTracing frameworks using tools such as Jaeger; Zipkin experience considered equivalent. Experience using one or more general purpose programming languages, including but not limited to: Java, C, C++, Swift/Objective C, Python, Go, C#, or JavaScript. Working knowledge of data structures, algorithms, highly concurrent programming, and software design patterns with instrumentation for observability Willing and able to learn new technologies at a rapid pace Previous open-source project use and/or active contributions desired Communication skills to work with client partners in articulating the vision of automation, observability, monitoring, DevSecOps, and DataOps and how they can drive value for applications at Amgen Experience enabling automation and application self-healing based on telemetry and events 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. Amgen provides 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. Amgen is an Equal Opportunity employer and will consider you without regard to your 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. PI115635063