Manager Aseptic Processing Jobs in Massachusetts

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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 longterm commercial manufacturing. The position requires deep technical expertise in aseptic processing combined with strong crossfunctional 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 riskbased justifications for highgrade aseptic manufacturing classification.
• Partner with quality, regulatory, engineering, and technical subjectmatter experts to align on strategy, execution, and readiness.

Regulatory and Inspection Readiness

• Ensure aseptic processing strategies are inspectionready to support commercial filings and regulatory approvals.
• Support internal audits and external regulatory inspections as a subjectmatter expert for aseptic processing and contamination control.
• Develop clear, defensible regulatory narratives for novel or nontraditional 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 crossfunctional stakeholders with differing priorities.
• Apply critical thinking and datadriven 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 handson 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 fastpaced, highly regulated environment and to manage complexity and ambiguity while delivering results.

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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

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.