Process Development Sr Scientist
Amgen · Thousand Oaks, CA
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Role summary
This Process Development Senior Scientist role at Amgen involves leading analytical chemistry efforts for late-stage manufacturing process development across diverse therapeutic modalities. The position requires defining analytical strategies, overseeing method qualification and transfer, managing external testing sites, and supporting regulatory submissions. The successful candidate will provide technical leadership to cross-functional teams while advancing process characterization and innovation within the organization.
What they're looking for
- Doctorate in analytical chemistry, biochemistry, or equivalent field
- Master's degree with 2+ years directly related life science experience
- 5-7+ years analytical chemistry experience in biopharmaceutical setting
- Strong background in analytical method development for biologics and monoclonal antibodies
- Proficiency in HPLC and capillary electrophoresis techniques
- Knowledge of regulatory requirements and experience authoring regulatory filings
- Understanding of GLP and GMP requirements and their phase-appropriate application
What you'll be doing
- Supervise and provide technical support to analytical team for late-stage product development
- Lead Attribute Sciences team for pivotal clinical process development program analytical work
- Define analytical target profiles and oversee method development, qualification, and transfer to QC
- Author technical reports and CMC sections for regulatory documents and respond to health authority questions
- Drive product characterization for process comparability studies and regulatory filings
Privacy & handoff
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