Process Development Sr Principal Scientist
Amgen · Thousand Oaks, CA
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Role summary
Amgen seeks a senior principal scientist to lead process development and lifecycle management of drug product formulations and fill/finish operations across multiple therapeutic modalities. The role involves directing commercialization teams, executing laboratory studies, supporting manufacturing operations, and driving continuous improvement through cross-functional collaboration and technical innovation. A doctoral degree with three years of scientific experience is required.
What they're looking for
- Doctorate in pharmacy, pharmaceutics, or related field with 3+ years scientific experience
- Master's degree with 6+ years scientific experience, or Bachelor's with 8+ years
- Experience with parenteral biologics process characterization, scale-up, and manufacturing
- Knowledge of stability testing, protein chemistry, freezing and drying impacts on products
- Familiarity with cGMP regulations, ICH guidelines, and regulatory inspections
- Statistical process control, design of experiments, and data analysis capabilities
What you'll be doing
- Lead drug product commercialization teams designing formulation and fill/finish processes across modalities
- Conduct laboratory studies documenting drug product design, development, and lifecycle management
- Troubleshoot manufacturing operations through process analysis, root cause investigation, and impact assessment
- Author technical protocols, regulatory submissions, and responses to regulatory inquiries
- Drive process improvements through innovation, cross-functional collaboration, and advanced data systems
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.