Director, Bioprocess / Process Development – Pivotal Drug Substance
Amgen · Cambridge, MA
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Role summary
This director-level role oversees bioprocess development and scale-up for drug substances across multiple sites, leading a team of 30+ scientists and engineers. Responsibilities include managing cell culture and purification processes for late-stage biologics programs, directing regulatory submissions, and advancing commercial manufacturing strategies. A doctorate with 4+ years of process development experience, or a master's degree with 8+ years, is required.
What they're looking for
- Doctorate degree and 4+ years process development experience, or equivalent education/experience combination
- 4+ years directly managing people and leading teams or programs
- PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related field preferred
- 10+ years biopharmaceutical process development experience preferred
- Deep expertise in cell culture bioreactor or downstream purification processes
- Strong understanding of late-stage biologics development, process validation, and regulatory interactions
- Demonstrated statistical analysis, technical decision-making, and senior-level communication skills
What you'll be doing
- Lead multi-site organization of 30+ scientists and engineers across cell culture and purification disciplines
- Recruit, develop, and retain diverse team; manage portfolio prioritization and organizational resourcing
- Advance drug substance processes through commercial development, characterization, lifecycle management, and control strategies
- Partner with engineering and manufacturing collaborators to enable process transfer and commercialization
- Author and review global regulatory filings and respond to regulatory agency inquiries
Privacy & handoff
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