Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)
Amgen
September 02, 2026
On-site
Thousand Oaks, CA
Operations
Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)
Responsibilities:
- Lead a global organization (30+ scientists/engineers) for synthetic/hybrid small molecule process development across early- and late-phase clinical and commercial portfolios.
- Drive technical and strategic solutions for development, characterization, technology transfer, and lifecycle management of drug substance manufacturing processes.
- Provide strategic oversight from early-phase through commercial advancement and lifecycle management.
- Establish engineering business/technology platforms; strengthen engineering capabilities and innovative practices.
- Author/review regulatory filings (IND/INDa/MAA) and responses to regulatory agency questions.
- Foster a culture of safety, quality, and compliance; ensure SOP adherence.
- Recruit, develop, and retain a high-performing/ddiverse team; manage portfolio prioritization, resources, and budget.
- Partner with manufacturing/CDMOs for technology transfer, validation, and supply; engage with external partner leadership.
- Drive innovative technologies to reduce development time and improve robustness/cost; identify process improvement opportunities.
- Contribute to scientific eminence (publications/patents/conferences) and support cross-functional leadership/change strategies.
Basic Qualifications:
- Doctorate + 5 years, OR Master’s + 9 years, OR Bachelor’s + 11 years scientific process development; plus 5+ years people management/organizational leadership.
Preferred Qualifications:
- PhD (Chemical Engineering or related); 10+ years synthetic/hybrid process development; SME (small molecule/peptide/oligo/bioconjugates); cGMP, scale-up, commercialization; tech transfer/CMOs; quality risk management; ICH/regulatory filing experience; QbD/statistics; executive communication; talent development; scientific community engagement.
Travel: 10–20%.
Benefits (as stated): Total Rewards Plan including retirement savings plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus/incentives (role-dependent), stock-based long-term incentives, time-off.
Application: Apply at careers.amgen.com; no application deadline (accepted until sufficient applications or candidate selection).
Responsibilities:
- Lead a global organization (30+ scientists/engineers) for synthetic/hybrid small molecule process development across early- and late-phase clinical and commercial portfolios.
- Drive technical and strategic solutions for development, characterization, technology transfer, and lifecycle management of drug substance manufacturing processes.
- Provide strategic oversight from early-phase through commercial advancement and lifecycle management.
- Establish engineering business/technology platforms; strengthen engineering capabilities and innovative practices.
- Author/review regulatory filings (IND/INDa/MAA) and responses to regulatory agency questions.
- Foster a culture of safety, quality, and compliance; ensure SOP adherence.
- Recruit, develop, and retain a high-performing/ddiverse team; manage portfolio prioritization, resources, and budget.
- Partner with manufacturing/CDMOs for technology transfer, validation, and supply; engage with external partner leadership.
- Drive innovative technologies to reduce development time and improve robustness/cost; identify process improvement opportunities.
- Contribute to scientific eminence (publications/patents/conferences) and support cross-functional leadership/change strategies.
Basic Qualifications:
- Doctorate + 5 years, OR Master’s + 9 years, OR Bachelor’s + 11 years scientific process development; plus 5+ years people management/organizational leadership.
Preferred Qualifications:
- PhD (Chemical Engineering or related); 10+ years synthetic/hybrid process development; SME (small molecule/peptide/oligo/bioconjugates); cGMP, scale-up, commercialization; tech transfer/CMOs; quality risk management; ICH/regulatory filing experience; QbD/statistics; executive communication; talent development; scientific community engagement.
Travel: 10–20%.
Benefits (as stated): Total Rewards Plan including retirement savings plan, medical/dental/vision, life/disability, flexible spending accounts, discretionary annual bonus/incentives (role-dependent), stock-based long-term incentives, time-off.
Application: Apply at careers.amgen.com; no application deadline (accepted until sufficient applications or candidate selection).