Senior Director, Bioprocess & Drug Substance Leadership

BioSpace; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Total Rewards Plan

Comprehensive benefits

Discretionary annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Director of Bioprocess / Process Development to lead drug substance development, characterization, scale-up, and support for Phase II/III to commercial programs. The role oversees 30+ scientists across Cambridge, MA and Thousand Oaks, CA, driving process excellence, safety, and innovation.

You will guide portfolios spanning monoclonal antibodies, bispecifics, and other biologics, steering technology deployment and regulatory engagement while shaping the science and strategic

Qualifications

• Doctorate or equivalent with substantial process development experience
• Experience leading large, multi-site bioprocess teams
• Strong background in cell culture and downstream purification
• Proven track record with regulatory interactions (IND/MA)

Responsibilities

• Lead multisite drug substance organization across cell culture and purification disciplines
• Recruit, develop, and retain diverse team; prioritize portfolios and resources
• Advance commercial process development, characterization, lifecycle management, and control strategies
• Partner with engineering, manufacturing, and external collaborators for process transfer and commercialization
• Author and review regulatory filings and respond to agency questions
• Drive development of innovative bioprocess technologies
• Contribute to scientific leadership through publications and conferences
• Participate in leadership discussions on business strategy and change management

Skills

Leadership

Bioprocess

Cell culture

Purification

Regulatory filings

Team management

Education

PhD in Biochemistry/Biochemical Engineering/Chemical Engineering

MS in Biochemical Engineering

BS in Biotechnology

Tools

Bioprocessing equipment

Process development software

Job description

Amgen seeks a Director of Bioprocess / Process Development to lead drug substance development, characterization, scale-up, and support for Phase II/III to commercial programs. The role oversees 30+ scientists across Cambridge, MA and Thousand Oaks, CA, driving process excellence, safety, and innovation.

You will guide portfolios spanning monoclonal antibodies, bispecifics, and other biologics, steering technology deployment and regulatory engagement while shaping the science and strategic