Senior Director, Bioprocess – Process Development

Responsibilities

• 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.

• 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).

• Doctorate degree
• Master’s degree
• Bachelor’s degree