23 days old

Process Development Scientist - Commercial Attribute Sciences

Thousand Oaks, CA 91360
  • Job Code

Job ID: R-99245
Location: Thousand Oaks, CA, US 91360

Amgen's Commercial Attribute Sciences group at our Thousand Oaks site is seeking for a Scientist. This individual will be a part of a team at the collaborate with Commercial Quality and Manufacturing, collaborating closely with internal and external manufacture and testing sites as well as the global Attribute Sciences network to ensure that site needs are addressed. The Scientist will also provide crucial support to commercial Attribute Sciences Team Lead (ASTL) for analytical leadership of large molecule commercial programs and collaborate with representatives from key functions within Process Development.

Key Responsibilities Include:

  • Act as method transfer lead for external and internal commercial manufacturing and Quality Control (QC) to prioritize and support method specific issues and investigations
  • Lead analytical activities at contract manufacturing and testing sites
  • Support New Product Introduction (NPI) programs and commercial program process life cycle management, including testing using multiple analytical methods to support process improvements, comparability and small-scale models
  • Support non-conformance related to product quality and support investigations of OOS/OOT root cause determinations
  • Support ASTLs for global regulatory filings ensuring success of commercial approval and launch
  • Support ASTLs for method life cycle management, including method transfers, qualifications, improvements, trending and remediation
  • Interpret results, author and review technical reports and assessments
  • Interact and collaborate with multiple functional areas in matrix environment, both at site and network levels

Basic Qualifications:

  • Doctorate degree
  • OR
  • Master's degree and 4 years of Scientific or Operations experience
  • OR
  • Bachelor's degree and 6 years of Scientific or Operations experience

Preferred Qualifications:

  • Knowledge of analytical methods/technologies used in biologics using one or more of the following: High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis (CE), Enzyme-Linked Immuno Sorbent Assay (ELISA) and/or other techniques
  • Good understanding of GMP requirements
  • Considerable expertise in troubleshooting and investigation of analytical testing
  • Extensive experience in method development, qualifications/transfers, and data analysis and trending
  • Solid understanding of protein therapeutics analytical life cycle development and analytical control strategy
  • Strong communication skills and ability to provide cross-functional leadership for analytical project management
  • Excellent technical writing skills and attention to details in authoring technical reports and regulatory filing documents
  • Experienced in working in a matrix environment
  • Familiarity with biopharmaceutical manufacturing processes
  • Familiarity with USP monographs and chapters, and ICH guidance documents related to analytical method transfer and validation etc
  • Ability to multitask, optimally plan and follow through on complex projects and their application in a manner

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.



Posted: 2020-05-07 Expires: 2020-06-07

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Process Development Scientist - Commercial Attribute Sciences

Thousand Oaks, CA 91360

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