Scientist/ Senior Engineer – Commercial Drug Product
Amgen · Thousand Oaks, CA
CMCFull-timeCompany career page
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What they're looking for
- Doctorate degree, or Master's degree with 2+ years relevant experience, or Bachelor's degree with 4+ years relevant experience
- Advanced degree in chemical engineering, pharmaceutical sciences, pharmaceutics, or related technical discipline preferred
- 3+ years drug product process development or process engineering experience
- Expertise in parenteral unit operations including formulation, filtration, filling, lyophilization, and inspection
- Strong statistical analysis, process monitoring, and data-driven problem-solving skills
- Experience leading cross-functional teams in matrixed environments
- Technical writing and regulatory documentation capabilities
What you'll be doing
- Serve as process engineering lead and SKU owner for drug product formulation, fill/finish, and lifecycle management
- Design and execute laboratory and on-site studies for process development, characterization, and scale-up activities
- Lead technology transfers including facility assessments, process gap analyses, and on-site manufacturing support
- Integrate process, product, manufacturing, quality, and regulatory data to ensure commercialization success
- Support manufacturing operations through process capability analysis, troubleshooting, and corrective actions
Privacy & handoff
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