Associate Director, Aseptic Process and Design

About the role

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.

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 B