Process Development Senior Scientist
Amgen · Thousand Oaks, CA
CMCFull-timeCompany career page
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Role summary
This role involves developing and implementing analytical methods and control strategies for late-phase clinical programs in synthetic small molecules, peptides, and siRNA therapeutics. The senior scientist will collaborate with process development teams, conduct release testing and characterization, and may oversee method transfers to contract manufacturers while supporting regulatory submissions.
What they're looking for
- Doctorate in analytical, organic, physical chemistry, pharmaceutical sciences, or related field
- 2+ years post-PhD pharmaceutical or biotech industry experience in process and product development
- Proficiency in analytical method development, validation, and transfer across testing phases
- Strong knowledge of small molecule analysis, structure elucidation, and solid-state characterization
- Hands-on experience with mass spectrometry, NMR, UV, FTIR, and physicochemical characterization techniques
- Familiarity with USP monographs, ICH/FDA guidance, GLP, and GMP requirements
- Excellent technical writing and cross-functional communication skills
What you'll be doing
- Define analytical control strategies and implement methodologies for late-phase clinical programs
- Develop, optimize, and validate analytical methods for small molecules, peptides, and siRNA testing
- Collaborate with drug substance and drug product development teams on project objectives
- Provide analytical data including purity analysis, chiral purity, and structure elucidation support
- Lead method transfer to contract manufacturers or testing labs and approve external protocols and reports
Privacy & handoff
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