Senior Bioprocess & Process Development Director

BioSpace; Cambridge (MA); On-site; USD 190,000 - 280,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Dental insurance

Vision coverage

Life and disability insurance

Flexible spending accounts

Annual bonus

Stock-based incentives

Time-off programs

Flexible work models

Job summary

Amgen seeks a Director of Bioprocess/Process Development to lead a multi-site drug substance organization, advancing cell culture and purification programs from Phase II/III through commercialization. Based in Cambridge, MA or Thousand Oaks, CA, you will guide a 30+ person team, emphasizing safety, innovation, and digital strategies.

You will oversee biologics programs including mAbs and biosimilars, drive process development, technology transfer, and lifecycle management while collaborating

Qualifications

• PhD or Master/ Bachelor with extensive leadership in biotech process development.
• Experience leading multi-site teams and complex cross-functional programs.
• Strong track record in process development for biologics and regulatory interactions.

Responsibilities

• Lead a high-impact drug substance organization across sites.
• Recruit, develop, and retain a diverse team; manage capacity and resources.
• Advance drug substance processes from development to lifecycle management and transfer.
• Partner with engineering, manufacturing, and external collaborators for tech transfer.
• Author/regulatory filings and respond to agency questions.
• Drive bioprocess tech advances and innovative platforms across Amgen networks.
• Contribute to scientific eminence through publications and patents.

Skills

Bioprocess development

Leadership

Process development

Cell culture

Regulatory filings

Cross-functional leadership

Team management

Education

PhD in Biochemistry/Biochemical Eng/Chemical Eng

Job description

Amgen seeks a Director of Bioprocess/Process Development to lead a multi-site drug substance organization, advancing cell culture and purification programs from Phase II/III through commercialization. Based in Cambridge, MA or Thousand Oaks, CA, you will guide a 30+ person team, emphasizing safety, innovation, and digital strategies.

You will oversee biologics programs including mAbs and biosimilars, drive process development, technology transfer, and lifecycle management while collaborating