Associate Director, Aseptic & Sterile Process Engineering at Bristol Myers Squibb

Compensation

$170,650 – $206,793/yr

Setup: Hybrid
Location: Harvard, Massachusetts
Type: Full-time
Level: not_specified

Description

The Associate Director, Aseptic & Sterile Process Engineering at Bristol Myers Squibb leads a technical team focused on developing and implementing aseptic and sterile processing strategies for advanced, automated manufacturing platforms in cell therapy. This role involves defining and justifying aseptic processing strategies, ensuring regulatory compliance, managing Aseptic Process Simulation (APS), controlling contamination, integrating with automation, and influencing cross-functional stakeholders.

Required Skills

Aseptic Processing
Sterile Manufacturing Operations
Contamination Control Strategies
Environmental Monitoring
Cleanroom Qualification
Regulatory Inspections
Technology Transfer Activities
Aseptic Process Simulations (media fills)
Automation
Robotic Operations
Closed Manufacturing Systems
Mechanical Sterile Connectors
Advanced Aseptic Interfaces

Additional Information

Required Previous Experiences: 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.
Preferred Qualifications: Advanced degree (Master's or PhD) in a relevant scientific or engineering discipline.
Experience with automated, robotic, or closed manufacturing systems.
Familiarity with mechanical sterile connectors or advanced aseptic interfaces.
Experience working with external equipment vendors or technology developers.
Strong written and verbal communication skills with the ability to influence across a matrixed organization.

About Bristol Myers Squibb

Bristol Myers Squibb

biopharmaNew York, NY, US

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