Director, Bioprocess / Process Development – Pivotal Drug Substance
Amgen
August 13, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Director, Bioprocess / Process Development – Pivotal Drug Substance
What You Will Do
In this leadership role, responsible for 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. Lead and develop a multi-site organization of 30+ scientists and engineers, driving program success, safety culture, technical excellence, innovation, automation, and digital strategies.
Key Responsibilities
- Lead a multi-functional drug substance organization integrating cell culture and purification across multiple sites.
- Recruit, develop, and retain a strong team; manage portfolio prioritization and resourcing.
- Advance integrated drug substance processes via commercial process development, characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators for process transfer and commercialization.
- Author/review global regulatory filings (IND/INDa/MA) and respond to regulatory questions.
- Drive bioprocess technology ideation, development, and deployment.
- Contribute through publications, patents, and external conferences.
- Serve on Drug Substance Technology extended leadership team for business/organizational change strategies.
Qualifications
Basic Qualifications:
- Doctorate degree + 4 years process development, OR Master’s + 8 years, OR Bachelor’s + 10 years.
- At least 4 years directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation (managerial and technical may overlap).
Preferred Qualifications:
- PhD in Biochemistry/Biochemical Engineering/Chemical Engineering or related field.
- 10+ years biopharmaceutical process development.
- Minimum 4 years people management.
- Expertise in cell culture bioreactor processes or downstream purification.
- Late-stage biologics knowledge (process design, characterization, validation/PPQ, regulatory interactions).
- Scientific/engineering leadership on complex cross-functional programs.
- Statistical data analysis, technical decision-making, senior-level communication.
- Coaching/mentoring talent; publications/patents/industry forums.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient number received or candidate selected.
What You Will Do
In this leadership role, responsible for 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. Lead and develop a multi-site organization of 30+ scientists and engineers, driving program success, safety culture, technical excellence, innovation, automation, and digital strategies.
Key Responsibilities
- Lead a multi-functional drug substance organization integrating cell culture and purification across multiple sites.
- Recruit, develop, and retain a strong team; manage portfolio prioritization and resourcing.
- Advance integrated drug substance processes via commercial process development, characterization, lifecycle management, and control strategy development.
- Partner with engineering, manufacturing, and external collaborators for process transfer and commercialization.
- Author/review global regulatory filings (IND/INDa/MA) and respond to regulatory questions.
- Drive bioprocess technology ideation, development, and deployment.
- Contribute through publications, patents, and external conferences.
- Serve on Drug Substance Technology extended leadership team for business/organizational change strategies.
Qualifications
Basic Qualifications:
- Doctorate degree + 4 years process development, OR Master’s + 8 years, OR Bachelor’s + 10 years.
- At least 4 years directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation (managerial and technical may overlap).
Preferred Qualifications:
- PhD in Biochemistry/Biochemical Engineering/Chemical Engineering or related field.
- 10+ years biopharmaceutical process development.
- Minimum 4 years people management.
- Expertise in cell culture bioreactor processes or downstream purification.
- Late-stage biologics knowledge (process design, characterization, validation/PPQ, regulatory interactions).
- Scientific/engineering leadership on complex cross-functional programs.
- Statistical data analysis, technical decision-making, senior-level communication.
- Coaching/mentoring talent; publications/patents/industry forums.
Application Instructions
- Apply via careers.amgen.com; no application deadline—applications accepted until sufficient number received or candidate selected.