Director, Bioprocess – Process Development
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • California • Massachusetts • United States
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Salary
💰 $184,494 - $249,609 per year
Job Level
About the role
- Be responsible for the development, characterization, scale‑up, and support of drug substance cell culture and purification processes
- Lead and develop a multi-site organization of 30+ scientists and engineers
- Drive program success, safety culture, technical excellence, innovation, automation, and digital strategies.
- Support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities
- Advance late-stage and commercial drug substance strategies across Amgen’s manufacturing network.
- 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, OR Master’s degree and 8 years of scientific process development experience, OR 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 of resources.
- PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline preferred
- 10+ years of experience in biopharmaceutical process development preferred
- 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).
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
scientific process developmentcell culturepurification processesbiopharmaceutical process developmentbioreactor processesdownstream purificationprocess designprocess characterizationvalidationregulatory interactions
Soft Skills
leadershipteam managementcoachingmentoringcommunicationtechnical decision-makingportfolio prioritizationorganizational resourcinginnovationchange management
Certifications
PhD in BiochemistryPhD in Biochemical EngineeringPhD in Chemical Engineering