Director, Bioprocess & Drug Substance Leadership

Amgen; Cambridge (MA); In loco; USD 184.000 - 250.000; Tempo pieno

Descrizione del lavoro

Amgen Inc. in Cambridge, MA and/or Thousand Oaks, CA is seeking a Director, Bioprocess / Process Development to lead drug substance cell culture and purification development from Phase II/III through marketing applications.

The role oversees a 30+ person team across sites, driving technical excellence, safety, innovation and digital strategies. You will shape late‑stage and commercial drug substance programs, mentor leaders, and collaborate with engineering, manufacturing and external partners

Competenze

• Doctorate degree with 4+ years in scientific process development or Master’s with 8+ years or Bachelor’s with 10+ years of experience in scientific process development.
• At least 4 years of direct people management or leadership experience leading teams, programs or allocating resources.

Mansioni

• Lead a high‑impact, multi‑functional drug substance organization across multiple sites.
• Recruit, develop, and retain a diverse team; manage portfolio prioritization and resources.
• Advance integrated drug substance processes through development, characterization, lifecycle management, and control strategy development.
• Partner with engineering, manufacturing and external collaborators to enable process transfer and commercialization.
• Author and review regulatory filings (IND/INDa/MA) and respond to questions from agencies.

Conoscenze

Leadership

People management

Biopharmaceutical process development

Formazione

PhD in Biochemistry/Biochemical Engineering/Chemical Engineering or related

Descrizione del lavoro

Amgen Inc. in Cambridge, MA and/or Thousand Oaks, CA is seeking a Director, Bioprocess / Process Development to lead drug substance cell culture and purification development from Phase II/III through marketing applications.

The role oversees a 30+ person team across sites, driving technical excellence, safety, innovation and digital strategies. You will shape late‑stage and commercial drug substance programs, mentor leaders, and collaborate with engineering, manufacturing and external partners