Director, Bioprocess & Drug Substance Development

Amgen SA; Cambridge (MA); On-site; USD 240,000 - 360,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock‑based long‑term incentives

Award‑winning time‑off plans

Flexible work models

Job summary

Amgen, located in Cambridge, MA, is seeking a Director of Bioprocess/Process Development to lead drug substance development from Phase II/III through commercialization.

You will direct a 30+ person team across sites, drive process characterization, scale-up, and lifecycle management, and partner across engineering, manufacturing, and external collaborators to enable successful tech transfer and regulatory readiness.

Qualifications

• PhD with senior leadership in biopharmaceutical process development.
• Strong track record directing multi-site teams across development stages.
• Experience leading complex cross-functional programs and regulatory interactions.

Responsibilities

• Lead a high‑impact, multi‑functional drug substance organization across sites.
• Recruit, develop, and retain a diverse team; manage portfolio prioritization.
• Advance integrated drug substance processes through development and lifecycle management.
• Partner with engineering, manufacturing, and external collaborators for tech transfer.
• Author and review global regulatory filings and respond to agency questions.
• Drive innovative bioprocess technologies and contribute to scientific eminence.
• Contribute to leadership strategies within the Drug Substance Technology group.

Skills

Leadership

People management

Statistical data analysis

Education

PhD in Biochemistry

Job description

Amgen, located in Cambridge, MA, is seeking a Director of Bioprocess/Process Development to lead drug substance development from Phase II/III through commercialization.

You will direct a 30+ person team across sites, drive process characterization, scale-up, and lifecycle management, and partner across engineering, manufacturing, and external collaborators to enable successful tech transfer and regulatory readiness.