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In this leadership role, you will be responsible for 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, you will lead and develop a multi‑site organization of 30+ scientists and engineers while driving program success, safety culture, technical excellence, innovation, automation, and digital strategies. You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network.
Job Responsibility
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
Requirements
Doctorate degree and 4 years of scientific process development experience
Master’s degree and 8 years of scientific process development experience
Bachelor’s degree and 10 years of scientific process development experience
at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Nice to have
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)
What we offer
Retirement and Savings Plan with generous company contributions