Director, Bioprocess / Process Development – Pivotal Drug Substance
Amgen
4 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
Director, Bioprocess / Process Development – Pivotal Drug Substance
What You Will Do
Lead the development, characterization, scale-up, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA.
Key Responsibilities
- Lead a multi-functional drug substance organization integrating cell culture and purification across multiple sites.
- Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing.
- Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators to enable successful process transfer and commercialization.
- Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions.
- Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.
- Contribute to scientific and regulatory eminence through publications, patents, and participation in external conferences/forums.
- Serve on the Drug Substance Technology extended leadership team and contribute to business, organizational, and change-management strategies.
Basic Qualifications
- Doctorate degree + 4 years scientific process development experience, OR
- Master’s degree + 8 years scientific process development experience, OR
- Bachelor’s degree + 10 years scientific process development experience
- Plus at least 4 years experience directly managing people and/or leadership experience leading teams/projects/programs or directing allocation/resources.
Preferred Qualifications
- PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
- 10+ years in biopharmaceutical process development
- Minimum 4 years directly managing people
- Deep expertise in cell culture bioreactor processes OR downstream purification processes
- Late-stage biologics development knowledge (process design, characterization, validation/PPQ, regulatory interactions)
- Ability to provide scientific/engineering leadership on complex cross-functional programs
- Statistical data analysis, technical decision-making, and senior-level communication
- Track record developing talent (coaching/mentoring/feedback)
- Active engagement in scientific community (publications/patents/industry forums)
Benefits (if applicable in section)
- Total Rewards Plan: comprehensive employee benefits package (retirement/savings plan, group medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus/incentive (role-dependent), stock-based long-term incentives, time-off plans, and flexible work models (where possible).
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient or a candidate is selected.
What You Will Do
Lead the development, characterization, scale-up, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA.
Key Responsibilities
- Lead a multi-functional drug substance organization integrating cell culture and purification across multiple sites.
- Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing.
- Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators to enable successful process transfer and commercialization.
- Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions.
- Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.
- Contribute to scientific and regulatory eminence through publications, patents, and participation in external conferences/forums.
- Serve on the Drug Substance Technology extended leadership team and contribute to business, organizational, and change-management strategies.
Basic Qualifications
- Doctorate degree + 4 years scientific process development experience, OR
- Master’s degree + 8 years scientific process development experience, OR
- Bachelor’s degree + 10 years scientific process development experience
- Plus at least 4 years experience directly managing people and/or leadership experience leading teams/projects/programs or directing allocation/resources.
Preferred Qualifications
- PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
- 10+ years in biopharmaceutical process development
- Minimum 4 years directly managing people
- Deep expertise in cell culture bioreactor processes OR downstream purification processes
- Late-stage biologics development knowledge (process design, characterization, validation/PPQ, regulatory interactions)
- Ability to provide scientific/engineering leadership on complex cross-functional programs
- Statistical data analysis, technical decision-making, and senior-level communication
- Track record developing talent (coaching/mentoring/feedback)
- Active engagement in scientific community (publications/patents/industry forums)
Benefits (if applicable in section)
- Total Rewards Plan: comprehensive employee benefits package (retirement/savings plan, group medical/dental/vision, life/disability, flexible spending accounts), discretionary annual bonus/incentive (role-dependent), stock-based long-term incentives, time-off plans, and flexible work models (where possible).
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient or a candidate is selected.