Associate Director, Aseptic & Sterile Process Engineering

Biopharma Careers; Harvard (MA); On-site; USD 171,000 - 207,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Job summary

Bristol Myers Squibb is seeking an Associate Director of Aseptic & Sterile Process Engineering in Devens, MA, to lead aseptic strategy for an automated cell therapy platform. You will define, justify, and sustain processing approaches to support regulatory approvals and long-term manufacturing, while influencing cross-functional teams without direct authority.

The role requires deep technical expertise in aseptic processing, environmental monitoring, and APS, with collaboration across quality,

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related discipline.
• 8+ years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing.
• Hands-on experience with aseptic processing and sterile manufacturing operations.
• 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.

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 subject-matter experts to align on strategy, execution, and readiness.

Skills

Aseptic processing

Regulatory inspections

Cross-functional collaboration

Data-driven decisions

Education

Bachelor’s degree in Engineering or related field

Advanced degree preferred

Tools

Automation systems experience

Robotics experience

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 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 pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in LosAngeles County only: If you live in or expect to work from LosAngeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application‑related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1601375 : Associate Director, Aseptic & Sterile Process Engineering