Process Development Sr Scientist - Synthetic Attribute Sciences

About the role

Amgen is hiring a Process Development Senior Scientist to join its Synthetic Attribute Sciences team, part of the integrated Pharmaceutical Attribute Sciences (iPAS) department in Thousand Oaks, CA. The team supports pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products. The scientist works with analysts and scientists developing analytical tools for late-phase synthetic programs across small molecules, synthetic peptides, siRNA and synthetic components of conjugates.

Key responsibilities

• Define analytical control strategies and implement methodologies supporting late-phase clinical programs
• Develop, optimize, authorize and validate analytical methods for attribute understanding and characterization across synthetic modalities
• Collaborate with drug substance and drug product process development colleagues
• Provide analytical data for purity analysis, chiral purity and structure elucidation using mass spectrometry
• May lead method transfer to a contract manufacturing organization or contract testing lab, and review and approve protocols and reports
• Support the project team lead in authoring technical reports and CMC sections in regulatory documents
• May lead and mentor a small group of scientists

Required profile

• Basic: PhD, PharmD or MD (with relevant post-doc); or Master's degree with 3 years of scientist experience; or Bachelor's degree with 5 years of scientist experience
• Preferred: PhD in Analytical, Organic, Physical Chemistry, Material Sciences or Pharmaceutical Sciences, with 2+ years of post-PhD experience in pharmaceutical or biotech process and product development
• Experience in conjugate method development, characterization and analytical control strategy, including mass spectrometry
• Hands-on experience in method development, validation and transfer for in-process, release and stability testing
• Experience transferring non-GMP and GMP production and testing to external contract organizations

Required skills

• Structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR
• Familiarity with USP monographs and ICH/FDA guidance on method transfer and validation, impurities and mutagenic impurities
• Solid understanding of GLP and GMP requirements
• Technical writing for methods, specifications, reports and regulatory filings
• Cross-functional leadership and excellent communication skills

What we offer

• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans and flexible work models where possible