Senior Director, Bioprocess​/Process Development – Pivotal Drug Substance

Career Category:
Process Development

Senior Director, Bioprocess/Process Development – Pivotal Drug Substance. Lead and develop a multi‑site organization of 30+ scientists and engineers, supporting commercial advancement of drug substance cell culture and purification processes for Phase II/III to marketing applications, located in Cambridge, MA and/or Thousand Oaks, CA.

• Lead a high‑impact, multi‑functional drug substance organization integrating cell culture and purification disciplines 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 network 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 Amgen’s scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.
• Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and change‑management strategies.

• Doctorate degree and 5 years of scientific process development experience, OR Master’s degree and 9 years, OR Bachelor’s degree and 11 years.
• At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing allocation of resources.

• PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline.
• 10+ years of experience in biopharmaceutical process development.
• Minimum of 4 years of experience directly managing people.
• Deep expertise in either cell culture bioreactor processes OR downstream purification processes.
• Strong understanding of late‑stage biologics development including process design, characterization, validation (PPQ), and regulatory interactions.
• Proven ability to provide scientific and engineering leadership on complex cross‑functional programs.
• Demonstrated experience in statistical data analysis, technical decision‑making, and senior‑level communication.
• Track record of developing talent through coaching, mentoring, and feedback.
• Active engagement in the scientific community (publications, patents, industry forums).

Expected annual salary range: USD – USD (excluding Puerto Rico). Total Rewards Plan includes health and welfare plans, retirement and savings plan, discretionary bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.