Aseptic & Sterile Process Engineering Lead, Cell Therapy

Biopharma Careers; Harvard (MA); On-site; USD 171,000 - 207,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Job summary

Bristol Myers Squibb is seeking an Associate Director of Aseptic & Sterile Process Engineering in Devens, MA, to lead aseptic strategy for an automated cell therapy platform. You will define, justify, and sustain processing approaches to support regulatory approvals and long-term manufacturing, while influencing cross-functional teams without direct authority.

The role requires deep technical expertise in aseptic processing, environmental monitoring, and APS, with collaboration across quality,

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related discipline.
• 8+ years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing.
• Hands-on experience with aseptic processing and sterile manufacturing operations.
• Experience with contamination control strategies, environmental monitoring, and cleanroom qualification.
• Direct experience leading or supporting Aseptic Process Simulations (media fills).
• Experience supporting regulatory inspections, commercial readiness, or technology transfer.

Responsibilities

• Serve as the technical authority for aseptic and sterile processing strategy for an advanced automated manufacturing environment.
• Lead the development of scientific and risk-based justifications for high-grade aseptic manufacturing classification.
• Partner with quality, regulatory, engineering, and subject-matter experts to align on strategy, execution, and readiness.

Skills

Aseptic processing

Regulatory inspections

Cross-functional collaboration

Data-driven decisions

Education

Bachelor’s degree in Engineering or related field

Advanced degree preferred

Tools

Automation systems experience

Robotics experience

Job description

Bristol Myers Squibb is seeking an Associate Director of Aseptic & Sterile Process Engineering in Devens, MA, to lead aseptic strategy for an automated cell therapy platform. You will define, justify, and sustain processing approaches to support regulatory approvals and long-term manufacturing, while influencing cross-functional teams without direct authority.

The role requires deep technical expertise in aseptic processing, environmental monitoring, and APS, with collaboration across quality,