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Process Development Principal Scientist

4 months ago

Thousand Oaks, United States Amgen Full time

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.

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 molecules and collaborate closely with Drug Substance, Drug Product and Product Quality colleagues.

  • Lead all attribute and analytical aspects of a program in pivotal clinical process 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 cGMP 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 a Scientist with these qualifications.Basic Qualifications:

  • Bachelors degree and 7 years of Scientific experience OR
Masters degree and 5 years of Scientific experience ORDoctorate degree PhD OR PharmD OR MD and 2 years of Scientific experiencePreferred Qualifications: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 characterizationKnowledge 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.Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate mannerHands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testingKnowledge 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 organizationsAbility to multitask managing deliverables on complex projects against timelinesStrong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver resultsExcellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documentThrive

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.

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.com

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.