Sr. Director, Aseptic Operational Support

Role: Senior Director overseeing enterprise aseptic and microbial control strategies at Bristol Myers Squibb, with a focus on sterility assurance and contamination prevention across global manufacturing sites. Responsibilities include defining enterprise-level policies, leading risk management and escalation pathways, establishing KPIs for program performance, fostering cross-site harmonization, and serving as technical authority for contamination events and regulatory inspections. The role involves providing expert guidance on environmental monitoring, CMO oversight, gowning protocols, and facility design to ensure compliance and continuous improvement. Qualifications: Bachelor’s degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field; 15+ years in microbiology, contamination control, or aseptic processing within the pharma industry; 8-10+ years in senior leadership roles with enterprise accountability. Experience across multiple manufacturing modalities (small molecule, biologics, cell/gene therapy), with deep knowledge of global regulatory frameworks (FDA, EMA, ICH, USP, PIC/S). Skills include enterprise thinking, technical authority in microbial sciences, executive communication, change leadership, data analytics, and cross-functional collaboration. Preferred: Advanced degree (M.S. or Ph.D.). The role is based in the US, potentially hybrid, with responsibilities spanning sterile and non-sterile manufacturing, risk management, and regulatory engagement, ensuring high standards of microbial control in pharma production.