Associate Director, Aseptic & Sterile Process Engineering

About the role

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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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 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.

Additional Information

This role requires the ability to work effectively in a fast-paced, highly regulated environment and to manage complexity and ambiguity while delivering results.

Compensation Overview

Devens - MA - US $170,650 - $206,793

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

Our benefits include Health Coverage Medical, pharmacy, dental, and vision care. Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits Include Paid Time Off US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays