Process Development Principal Scientist

HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Process Development Principal Scientist Live What you will do Lets do this. Lets change the world. In this vital role you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid Drug Products. Lead the attribute and analytical aspects of a program in pivotal clinical process development with a focus on drug product development while working cross-functionally within a Product development team Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization Lead method transfer and support of cGMP drug product manufacturing activities at internal manufacturing, and contract manufacturing and testing sites Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Bachelors degree and 7 years of Scientific experience OR Masters degree and 5 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Scientific experience Preferred Qualifications: Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development. Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner Hands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development. Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations Ability to multitask managing deliverables on complex projects against timelines Strong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.