Aseptic & Sterile Process Engineering Lead, Cell Therapy Automation

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

Job summary

Bristol Myers Squibb seeks an Associate Director of Aseptic & Sterile Process Engineering to lead aseptic and sterile processing strategy for an advanced automated manufacturing platform. This role requires deep technical expertise, cross-functional leadership, and the ability to influence outcomes in a matrixed environment.

The position focuses on regulatory readiness, process simulation leadership (media fills), and collaboration with QA, regulatory, engineering, and microbiology teams to

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related field.
• Minimum 8 years in pharma/biologics/cell and gene therapy manufacturing.
• Hands-on aseptic processing and sterile manufacturing experience.
• Direct experience with Aseptic Process Simulations (media fills).

Responsibilities

• Serve as the technical authority for aseptic and sterile processing strategy.
• Lead scientific and risk-based justifications for high-grade aseptic manufacturing.
• Collaborate with QA, regulatory, engineering, and SMEs to align strategy and readiness.
• Own and lead Aseptic Process Simulation strategy, execution, and lifecycle management.
• Define and maintain an integrated contamination control strategy.

Skills

Cross-functional leadership

Technical leadership

Matrixed influence

Regulatory readiness

Education

Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or related

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

Job description

Bristol Myers Squibb seeks an Associate Director of Aseptic & Sterile Process Engineering to lead aseptic and sterile processing strategy for an advanced automated manufacturing platform. This role requires deep technical expertise, cross-functional leadership, and the ability to influence outcomes in a matrixed environment.

The position focuses on regulatory readiness, process simulation leadership (media fills), and collaboration with QA, regulatory, engineering, and microbiology teams to