Senior Director, Bioprocess – Process Development

Amgen

Senior Director leading bioprocess development for drug substance at Amgen. Overseeing a multi-functional team while advancing commercial strategies in biopharmaceuticals.

Posted 5/28/2026full-timeCambridge • California, Massachusetts • 🇺🇸 United StatesSenior💰 $202,943 - $274,570 per yearWebsite

About the role

Key responsibilities & impact

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
Play a key role in advancing 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.

Requirements

What you’ll need

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

Benefits

Comp & perks

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.

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Applicant Tracking System Keywords

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Hard Skills & Tools

biopharmaceutical process developmentcell culture processesdownstream purification processesprocess characterizationprocess validationstatistical data analysistechnical decision-makingregulatory filingsbioprocess technologieslifecycle management

Soft Skills

leadershipteam managementcoachingmentoringcommunicationinnovationcollaborationorganizational resourcingportfolio prioritizationsafety culture

Certifications

Doctorate degreeMaster’s degreeBachelor’s degree