Associate Director, Aseptic Process and Design

Bristol Myers Squibb • Devens, MA

1d • $161,950 - $209,976 • Hybrid

About The Position

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.

Requirements

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
• 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

Nice To Haves

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.

Responsibilities

• 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).
• 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.
• 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.
• 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.
• 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.
• 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).
• 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.

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays
• 160 hours of paid vacation annually
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level