Associate Director, Aseptic & Sterile Process Engineering

Bristol Myers Squibb

Devens, MA, United States
Base: $170,650 - $206,793; bonus/equity: not speci...
On-site
Aseptic processing strategy
Contamination control strategy
Aseptic process simulation (aps)
Bristol Myers Squibb is seeking an Associate Director for Aseptic & Sterile Process Engineering to lead aseptic processing strategies and ensure regulatory compliance within an advanced automated manufacturing environment. The role emphasizes technical expertise, cross-functional collaboration, and leadership in a fast-paced, highly regulated industry

Job Summary

  • Serve as the technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy.
  • Lead the development of scientific and risk-based justifications for high-grade aseptic manufacturing classification and ensure aseptic processing strategies are inspection-ready.
  • Collaborate closely with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking an Associate Director for Aseptic & Sterile Process Engineering to lead aseptic processing strategies and ensure regulatory compliance within an advanced automated manufacturing environment. The role emphasizes technical expertise, cross-functional collaboration, and leadership in a fast-paced, highly regulated industry.

Salary

Base: $170,650 - $206,793; Bonus/Equity: Not specified; Benefits: Included

Skills & Requirements

Must-have

  • aseptic processing strategy
  • contamination control strategy
  • Aseptic Process Simulation (APS)
  • regulatory inspection readiness
  • advanced automated manufacturing

Nice-to-have

  • cross-functional leadership
  • influence outcomes
  • emerging technologies
  • robotic aseptic operations

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter