Associate Director, Aseptic & Sterile Process Engineering

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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Position Summary

The Associate Director, Aseptic & Sterile Process Engineering will serve as a technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy.

This role is responsible for defining, justifying, and sustaining aseptic processing strategies that support regulatory approval and long‑term commercial manufacturing. The position requires deep technical expertise in aseptic processing combined with strong cross‑functional leadership and the ability to influence outcomes in a matrixed environment.

Duties/Responsibilities

Aseptic Processing Strategy

• 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.

Regulatory and Inspection 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.
• Develop clear, defensible regulatory narratives for novel or non‑traditional manufacturing approaches.

Aseptic Process Simulation (APS)

• Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management.
• Design APS approaches that account for automated and robotic operations, closed or functionally closed processing, and novel material flows.
• Ensure APS success through robust system and process design.

Contamination Control and Microbial Strategy

• Define and maintain an integrated contamination control strategy aligned with advanced manufacturing technologies.
• Collaborate with microbiology and contamination control experts to ensure alignment of environmental monitoring, cleaning, and qualification strategies.
• Evaluate and incorporate emerging technologies or methodologies where appropriate.

Integration with Automation and Equipment Design

• Collaborate closely with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design.
• Partner with external equipment suppliers and technology developers to evaluate and mature robotic aseptic operations and sterile connection technologies.
• Serve as a technical advisor for aseptic risks associated with advanced automation.

Leadership and Influence

• Lead primarily through technical expertise, influence, and collaboration rather than direct authority.
• Facilitate alignment across cross‑functional stakeholders with differing priorities.
• Apply critical thinking and data‑driven decision making to resolve complex technical and organizational challenges.

Reporting Relationship

This role will report through the Cell Therapy Automation Site Deployment team.

Qualifications

Required Qualifications

• 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 contamina