Associate Director, Aseptic & Sterile Process Engineering
Bristol Myers Squibb
September 03, 2026
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- Serve as technical leader for aseptic and sterile processing strategy supporting an advanced automated manufacturing platform for cell therapy.
- Define, justify, and sustain aseptic processing strategies for regulatory approval and long-term commercial manufacturing; lead cross-functionally in a matrixed environment.
Duties/Responsibilities
- Aseptic Processing Strategy: technical authority; lead scientific/risk-based justifications for high-grade aseptic classification; partner with quality, regulatory, engineering, and subject-matter experts.
- Regulatory and Inspection Readiness: ensure inspection-ready strategies for commercial filings/approvals; support internal audits and external inspections; develop defensible regulatory narratives for novel approaches.
- Aseptic Process Simulation (APS): own/lead media-fill strategy, execution, investigation, and lifecycle management; design APS for automated/robotic, closed processing, and novel material flows; ensure robust system/process design.
- Contamination Control and Microbial Strategy: define/maintain integrated contamination control strategy; align environmental monitoring, cleaning, and qualification; evaluate emerging methods.
- Integration with Automation and Equipment Design: ensure aseptic principles are incorporated into system design; partner with suppliers on robotic aseptic ops and sterile connection technologies; advise on aseptic risks.
- Leadership: influence via technical expertise and data-driven decision making.
Qualifications
Required:
- Bachelor’s in Engineering/Biotech/Pharm Sciences/Microbiology or related.
- 8+ years in pharmaceutical/biologics/cell & gene therapy manufacturing.
- Hands-on aseptic and sterile manufacturing experience.
- Contamination control, environmental monitoring, and cleanroom qualification experience.
- Direct APS (media fills) leadership/support.
- Experience supporting regulatory inspections, commercial readiness, or tech transfer.
Preferred:
- Master’s/PhD.
- Automated/robotic/closed systems experience.
- Mechanical sterile connector/advanced aseptic interface familiarity.
- Experience with equipment vendors/technology developers.
- Strong written/verbal communication; influence across matrix.
Reporting Relationship
- Reports through the Cell Therapy Automation Site Deployment team.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k), disability and life insurance, and related financial protections.
- Paid time off options (varies by location/employee type).
Compensation Overview (explicit)
- Devens, MA (US): $170,650–$206,793.
Application Instruction
- Apply even if your resume doesn’t perfectly match the role requirements.
- Serve as technical leader for aseptic and sterile processing strategy supporting an advanced automated manufacturing platform for cell therapy.
- Define, justify, and sustain aseptic processing strategies for regulatory approval and long-term commercial manufacturing; lead cross-functionally in a matrixed environment.
Duties/Responsibilities
- Aseptic Processing Strategy: technical authority; lead scientific/risk-based justifications for high-grade aseptic classification; partner with quality, regulatory, engineering, and subject-matter experts.
- Regulatory and Inspection Readiness: ensure inspection-ready strategies for commercial filings/approvals; support internal audits and external inspections; develop defensible regulatory narratives for novel approaches.
- Aseptic Process Simulation (APS): own/lead media-fill strategy, execution, investigation, and lifecycle management; design APS for automated/robotic, closed processing, and novel material flows; ensure robust system/process design.
- Contamination Control and Microbial Strategy: define/maintain integrated contamination control strategy; align environmental monitoring, cleaning, and qualification; evaluate emerging methods.
- Integration with Automation and Equipment Design: ensure aseptic principles are incorporated into system design; partner with suppliers on robotic aseptic ops and sterile connection technologies; advise on aseptic risks.
- Leadership: influence via technical expertise and data-driven decision making.
Qualifications
Required:
- Bachelor’s in Engineering/Biotech/Pharm Sciences/Microbiology or related.
- 8+ years in pharmaceutical/biologics/cell & gene therapy manufacturing.
- Hands-on aseptic and sterile manufacturing experience.
- Contamination control, environmental monitoring, and cleanroom qualification experience.
- Direct APS (media fills) leadership/support.
- Experience supporting regulatory inspections, commercial readiness, or tech transfer.
Preferred:
- Master’s/PhD.
- Automated/robotic/closed systems experience.
- Mechanical sterile connector/advanced aseptic interface familiarity.
- Experience with equipment vendors/technology developers.
- Strong written/verbal communication; influence across matrix.
Reporting Relationship
- Reports through the Cell Therapy Automation Site Deployment team.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k), disability and life insurance, and related financial protections.
- Paid time off options (varies by location/employee type).
Compensation Overview (explicit)
- Devens, MA (US): $170,650–$206,793.
Application Instruction
- Apply even if your resume doesn’t perfectly match the role requirements.