Associate Director, Aseptic & Sterile Process Engineering

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. Position Summary The Associate Director, Aseptic & Sterile Process Engineering will serve as a technical leader for aseptic and sterile processing strategy supporting an advanced, automated manufacturing platform for cell therapy. This role is responsible for defining, justifying, and sustaining aseptic processing strategies that support regulatory approval and long‑term commercial manufacturing. The position requires deep technical expertise in aseptic processing combined with strong cross‑functional leadership and the ability to influence outcomes in a matrixed environment. Duties/Responsibilities Aseptic Processing Strategy • Serve as the technical authority for aseptic and sterile processing strategy for an advanced automated manufacturing environment. • Lead the development of scientific and risk‑based justifications for high‑grade aseptic manufacturing classification. • Partner with quality, regulatory, engineering, and technical subject‑matter experts to align on strategy, execution, and readiness. Regulatory and Inspection Readiness • Ensure aseptic processing strategies are inspection‑ready to support commercial filings and regulatory approvals. • Support internal audits and external regulatory inspections as a subject‑matter expert for aseptic processing and contamination control. • Develop clear, defensible regulatory narratives for novel or non‑traditional manufacturing approaches. Aseptic Process Simulation (APS) • Own and lead Aseptic Process Simulation (media fill) strategy, execution, investigation, and lifecycle management. • Design APS approaches that account for automated and robotic operations, closed or functionally closed processing, and novel material flows. • Ensure APS success through robust system and process design. Contamination Control and Microbial Strategy • Define and maintain an integrated contamination control strategy aligned with advanced manufacturing technologies. • Collaborate with microbiology and contamination control experts to ensure alignment of environmental monitoring, cleaning, and qualification strategies. • Evaluate and incorporate emerging technologies or methodologies where appropriate. Integration with Automation and Equipment Design • Collaborate closely with automation, equipment, and process development teams to ensure aseptic principles are incorporated into system design. • Partner with external equipment suppliers and technology developers to evaluate and mature robotic aseptic operations and sterile connection technologies. • Serve as a technical advisor for aseptic risks associated with advanced automation. Leadership and Influence • Lead primarily through technical expertise, influence, and collaboration rather than direct authority. • Facilitate alignment across cross‑functional stakeholders with differing priorities. • Apply critical thinking and data‑driven decision making to resolve complex technical and organizational challenges. Reporting Relationship This role will report through the Cell Therapy Automation Site Deployment team. Qualifications Required Qualifications • Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related scientific or technical discipline. • Minimum of 8 years of experience in pharmaceutical, biologics, or cell and gene therapy manufacturing. • Significant hands‑on experience with aseptic processing and sterile manufacturing operations. • Demonstrated experience with contamination control strategies, environmental monitoring, and cleanroom qualification. • Direct experience leading or supporting Aseptic Process Simulations (media fills). • Experience supporting regulatory inspections, commercial readiness, or technology transfer activities. Preferred Qualifications • Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline. • Experience with automated, robotic, or closed manufacturing systems. • Familiarity with mechanical sterile connectors or advanced aseptic interfaces. • Experience working with external equipment vendors or technology developers. • Strong written and verbal communication skills with the ability to influence across a matrixed organization. Additional Information • This role requires the ability to work effectively in a fast‑paced, highly regulated environment and to manage complexity and ambiguity while delivering results. BMSCART #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: $170,650 - $206,793 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, a