Aseptic & Sterile Process Engineering Lead

Bristol Myers Squibb EU Policy; Harvard (MA); On-site; USD 171,000 - 207,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k)

Job summary

Bristol Myers Squibb is seeking an Associate Director, Aseptic & Sterile Process Engineering to lead aseptic strategy for an automated cell therapy manufacturing platform. This role requires deep technical expertise, cross-functional leadership, and a track record in regulatory readiness.

The position reports to the Cell Therapy Automation Site Deployment team and offers a competitive compensation package and benefits. Based in Devens, MA with an emphasis on advanced manufacturing and innovation.

Qualifications

• Bachelor’s degree in a scientific or technical discipline as listed above.
• Minimum of 8 years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing.
• Significant hands-on experience with aseptic processing and sterile manufacturing operations.
• Demonstrated 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 activities.

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 technical subject-matter experts to align on strategy, execution, and readiness.
• Ensure aseptic processing strategies are inspection-ready to support commercial filings and regulatory approvals.
• Support internal audits and external regulatory inspections as a subject-matter expert for aseptic processing and contamination control.
• Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management.
• Define and maintain an integrated contamination control strategy aligned with advanced manufacturing technologies.
• Collaborate with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design.
• Lead through technical expertise, influence, and collaboration within a matrixed organization.

Education

Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related scientific or technical discipline

Advanced degree (Master’s or PhD) in a relevant discipline

Job description

Bristol Myers Squibb is seeking an Associate Director, Aseptic & Sterile Process Engineering to lead aseptic strategy for an automated cell therapy manufacturing platform. This role requires deep technical expertise, cross-functional leadership, and a track record in regulatory readiness.

The position reports to the Cell Therapy Automation Site Deployment team and offers a competitive compensation package and benefits. Based in Devens, MA with an emphasis on advanced manufacturing and innovation.