Associate Director, Aseptic Process and Design

Bristol-Myers Squibb; New Brunswick (NJ); On-site; USD 162,000 - 196,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Comprehensive medical/dental/vision

Job summary

Bristol Myers Squibb is seeking an experienced professional to lead aseptic process design, qualification and lifecycle management at our New Jersey sites. You will collaborate with Quality, Manufacturing and Validation teams to drive process improvements, ensure sterility, and support regulatory submissions.

The role emphasizes cross-site leadership, compliance with cGMP, and continuous improvement in aseptic processing, with up to 25% travel as needed.

Qualifications

• Education requirements include a bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or related field.
• 5–10+ years of experience in aseptic/sterile manufacturing with cleanroom exposure.
• Experience with cGMP, FDA/EMA guidelines and validation activities.

Responsibilities

• Design and develop aseptic manufacturing processes, including fill/finish and sterile processing systems.
• Lead process optimization to improve yield, reliability, and sterility assurance.
• Support qualification, validation, and lifecycle management of aseptic systems.
• Define enterprise APS/media fill strategy and ensure regulatory alignment.
• Support contamination control, environmental monitoring, and sterilization practices.

Skills

Aseptic processing

Process optimization

Process validation

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Project management

Education

B.S. in Microbiology

B.S. in Pharmaceutical Sciences

Biochemistry/Chemical Engineering basics

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.

Key Responsibilities

Aseptic Process & Facility Design

Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems. Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks. Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems).

Process Development, Optimization & Scale-Up

Establish microbial critical process parameters (CPPs) and develop robust aseptic manufacturing formulas. Lead process optimization efforts to improve yield, reliability, and sterility assurance. Support scale-up and technology transfer from development to commercial manufacturing.

Qualification, Validation & Lifecycle Management

Support and/or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines. Develop and execute process validation strategies, including media fills and continued process verification. Ensure processes remain in control through lifecycle monitoring and continuous improvement.

Aseptic Process Simulation (APS) & Media Fill Program

Define the enterprise APS/media fill strategy, including program governance, intervention classification, acceptance criteria, and continuous improvement expectations. Provide expert oversight and standardization of smoke study program design and execution, ensuring aerodynamic qualification of aseptic processing zones aligns with current regulatory and industry standards. Establish and maintain enterprise-level policies governing media fill frequency, unit operation coverage, failure investigation protocols, and remediation pathways. Facilitate cross-site learning and consistency in APS program design across the BMS network by sharing best practices, regulatory trends, and lessons learned — supporting continuous improvement while respecting site program ownership.

Contamination Control & Sterility Assurance

Support sites in integrating Contamination Control & Sterility (CCS) requirements into process design and operational practices across facilities, equipment, and processes. Assess risks related to microbial contamination and define mitigation strategies. Integrate environmental monitoring, cleaning validation, and sterilization practices into process design.

Regulatory Compliance & Quality Integration

Ensure compliance with cGMP, FDA, EU GMP Annex 1, ISO standards, and ICH guidelines. Support regulatory submissions, inspections, and audits with technical documentation. Develop SOPs and technical documentation and provide input on batch records for aseptic processes. Assist sites in developing and maintaining inspection-readiness materials for aseptic process design, CCS, and APS topics; serve as a technical SME resource alongside site teams during regulatory inspections (FDA, EMA, PMDA, and other health authorities).

Cross-Functional Collaboration & Technical Leadership

Partner with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects. Provide SME support for troubleshooting and deviation investigations. Lead or contribute to capital projects, technology transfers, and process improvements.

Qualifications & Experience

• Education Required:B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
• Experience 5–10+ years (mid-level) in aseptic/sterile manufacturing.
• Hands-on experience in cleanroom and aseptic operations environments.
• Strong knowledge of Aseptic processing, sterile manufacturing, and contamination control, Cleanroom design and operation (ISO classifications), Fill/finish operations and sterile filtration and Sterilization technologies (steam, filtration, VHP, etc.).
• Experience with process validation, qualification, and GMP manufacturing systems.
• Familiarity with cGMP (FDA 21 CFR Parts 210/211), EU GMP Annex 1 / ISO 13408 and ICH Q8/Q9/Q10 principles.
• Understanding contamination control strategies and risk-based approaches.
• Ability to perform root cause analysis, risk assessments, and process troubleshooting.
• Strong data analysis and process performance evaluation capabilities.
• Experience with Equipment commissioning and startup, Process optimization and continuous improvement, and Managing timelines and cross-functional deliverables.
• Strong project management and organizational skills.
• Attention to detail and strong documentation discipline.
• Effective communication and cross-functional collaboration.
• Leadership and coaching capability.
• Travel: This position requires up to 25% of travel.
• Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.

Compensation Overview

• Devens - MA - US: $173,280 - $209,976
• Madison - Giralda - NJ - US: $161,950 - $196,246
• New Brunswick - NJ - US: $161,950 - $196,246
• Princeton - NJ - US: $161,950 - $196,246
• 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-accessibility to 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 Los Angeles County only: 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://career… sm…

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.