Lead Scientist - Protein Therapeutics Process Development
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Benefits offered by this job
Job summary
Amgen seeks a Process Development Senior Scientist to advance early-stage large-molecule programs by characterizing process and product properties and ensuring quality attributes across pipelines. You will lead analytical efforts, apply MS and chromatographic techniques, and drive regulatory-ready data packages.
You will collaborate with cross-functional teams, design experiments to understand attributes and stability, and support drug substance/product development and tech transfer, while
Qualifications
- PhD or equivalent with post‑doc experience preferred.
- Strong expertise in analytical method development, qualification, and troubleshooting.
- Experience with protein therapeutics characterization and quality attributes.
- Familiarity with GMP compliance and regulatory expectations.
Responsibilities
- Provide analytical leadership for early-stage programs.
- Design experiments to understand therapeutic protein attributes and stability.
- Apply analytical methods to characterize protein therapeutics and assess QA attributes.
- Evaluate method performance and support regulatory submissions and tech transfer.
- Stay current with emerging analytical technologies and adapt strategies.
Skills
Education
Tools
Job description
Amgen seeks a Process Development Senior Scientist to advance early-stage large-molecule programs by characterizing process and product properties and ensuring quality attributes across pipelines. You will lead analytical efforts, apply MS and chromatographic techniques, and drive regulatory-ready data packages.
You will collaborate with cross-functional teams, design experiments to understand attributes and stability, and support drug substance/product development and tech transfer, while
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