Senior Director, Bioprocess / Process Development – Pivotal Drug Substance
Amgen
5 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Senior Director, Bioprocess / Process Development – Pivotal Drug Substance
Responsibilities
- Lead development, characterization, scale-up, and support of drug substance cell culture and purification processes to enable commercial advancement (Phase II/III through marketing applications).
- Lead a multi-site organization (30+ scientists/engineers) focused on safety culture, technical excellence, innovation, automation, and digital strategies.
- Drive integrated drug substance process development, characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators to enable successful process transfer and commercialization.
- Author/review global regulatory filings (IND/INDa/MA) and respond to regulator questions.
- Drive bioprocess technology ideation, development, and deployment.
- Contribute to scientific/regulatory eminence via publications, patents, and external conferences.
Qualifications
Basic:
- Doctorate + 5 years process development experience OR Master’s + 9 years OR Bachelor’s + 11 years.
- At least 5 years managing people and/or leadership experience (teams/projects/programs/resources).
Preferred:
- PhD in relevant discipline; 10+ years biopharmaceutical process development.
- 4+ years people management.
- Deep expertise in cell culture bioreactors or downstream purification.
- Late-stage biologics knowledge (process design, characterization, validation/PPQ, regulatory interactions).
- Statistical data analysis, technical decision-making, senior communication; talent development; active scientific community engagement.
Benefits (Total Rewards Plan, eligibility-based)
- Medical/dental/vision, life/disability, retirement/savings contributions, discretionary bonus, stock-based long-term incentives, time-off, flexible work models (where possible).
Application
- Apply via careers.amgen.com; no application deadline; accepts applications until sufficient candidates/selection. Sponsorship not guaranteed.
Responsibilities
- Lead development, characterization, scale-up, and support of drug substance cell culture and purification processes to enable commercial advancement (Phase II/III through marketing applications).
- Lead a multi-site organization (30+ scientists/engineers) focused on safety culture, technical excellence, innovation, automation, and digital strategies.
- Drive integrated drug substance process development, characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators to enable successful process transfer and commercialization.
- Author/review global regulatory filings (IND/INDa/MA) and respond to regulator questions.
- Drive bioprocess technology ideation, development, and deployment.
- Contribute to scientific/regulatory eminence via publications, patents, and external conferences.
Qualifications
Basic:
- Doctorate + 5 years process development experience OR Master’s + 9 years OR Bachelor’s + 11 years.
- At least 5 years managing people and/or leadership experience (teams/projects/programs/resources).
Preferred:
- PhD in relevant discipline; 10+ years biopharmaceutical process development.
- 4+ years people management.
- Deep expertise in cell culture bioreactors or downstream purification.
- Late-stage biologics knowledge (process design, characterization, validation/PPQ, regulatory interactions).
- Statistical data analysis, technical decision-making, senior communication; talent development; active scientific community engagement.
Benefits (Total Rewards Plan, eligibility-based)
- Medical/dental/vision, life/disability, retirement/savings contributions, discretionary bonus, stock-based long-term incentives, time-off, flexible work models (where possible).
Application
- Apply via careers.amgen.com; no application deadline; accepts applications until sufficient candidates/selection. Sponsorship not guaranteed.