Associate Director, Aseptic Process and Design

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 an