Process Development Principal Scientist
Amgen · Cambridge, MA
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Role summary
Join Amgen's Process Development organization as a Principal Scientist leading analytical strategy for commercial manufacturing processes. This role involves directing attribute sciences and analytical methodologies for synthetic and hybrid therapeutics, managing method transfers to manufacturing sites, and authoring regulatory documentation. The position requires cross-functional collaboration and expertise in analytical control strategies and product characterization.
What they're looking for
- PhD, PharmD, or MD with 3+ years of relevant discipline experience
- Master's degree with 6+ years of scientific experience alternative
- Bachelor's degree with 8+ years of scientific experience alternative
- Expertise in small molecule analysis, chromatography, and spectroscopy techniques
- Knowledge of GLP, GMP requirements and phase-appropriate application
- Experience with analytical method development, validation, and transfer
- Familiarity with pharmacopeia standards and ICH/FDA guidance documents
What you'll be doing
- Lead analytical and attribute strategies for clinical process development programs
- Define analytical control strategies and develop methodologies for late-phase programs
- Manage method transfer and support cGMP manufacturing at internal and contract sites
- Author technical reports and CMC sections for regulatory submissions
- Drive product characterization for comparability studies and regulatory filings
Privacy & handoff
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