Associate Director, Aseptic Process and Design

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. #LI-Hybrid We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. 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.