Associate Director, Environmental Monitoring Program Coordination

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 Establish and lead the global governance model for Environmental Monitoring across a network of biologics and cell therapy manufacturing sites, including internal sites, partner sites, and external manufacturing organizations as applicable. Define harmonized EM program standards, procedures, sampling strategy expectations, monitoring frequencies, alert/action limit principles, escalation pathways, data review requirements, and periodic review processes across the manufacturing network. Lead network-level EM data trending and governance, including comparison of site trends, identification of recurring or systemic adverse signals, evaluation of seasonal or geographic variability, and assessment of cross-site contamination control risks. Develop and maintain a consistent global approach for EM trend evaluation, adverse trend definition, excursion categorization, impact assessment, mitigation planning, CAPA linkage, and effectiveness monitoring. Translate local and network-level EM signals into actionable risk assessments, mitigation plans, contamination control improvements, and governance decisions in partnership with site Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, and Sterility Assurance teams. Coordinate cross-site response to significant or recurring EM excursions, including alignment on containment recommendations, investigation strategy, product quality impact considerations, root cause expectations, mitigation ownership, and effectiveness verification. Serve as the global subject matter expert for environmental monitoring during deviation investigations, contamination events, aseptic process simulations, facility start-up, process transfers, new product introductions, campaign readiness, network governance reviews, and regulatory inspections. Ensure site EM programs are aligned with the global Contamination Control Strategy, aseptic processing expectations, facility qualification state, cleaning and disinfection strategy, personnel gowning controls, manufacturing process risk assessments, and applicable health authority expectations. Partner with manufacturing sites to evaluate environmental signals in relation to operational behaviors, material and personnel flows, interventions, cleaning practices, HVAC performance, facility maintenance, process design, and site-specific operating models. Lead global governance forums such as EM trend review boards, contamination control councils, site escalation meetings, network health reviews, and cross-site mitigation forums for significant or recurring environmental monitoring signals. Establish global metrics and dashboards to monitor EM program health across the network, including sample completion, excursion rates, adverse trend closure, investigation timeliness, CAPA effectiveness, alert/action frequency, recurrence, and inspection readiness indicators. Support regulatory inspections and internal audits by presenting the global EM program structure, network governance model, data trend strategy, site-to-site consistency, excursion management approach, mitigation rationale, and continuous improvement actions in a clear and scientifically defensible manner. Provide leadership, coaching, and technical guidance to global QC microbiology, EM coordination, site Quality, and cross-functional stakeholders to strengthen contamination control awareness and data-driven decision-making across the network. Evaluate and implement global digital systems, LIMS/MODA or equivalent EM data platforms, electronic trending tools, dashboards, data standards, and data integrity controls to improve program efficiency, comparability, traceability, and audit readiness across sites. Support network expansion, new product introduction, technology transfer, facility modification, process changes, cleaning/disinfection changes, and validation activities by assessing EM program impact and ensuring appropriate monitoring controls are established consistently across sites. Maintain awareness of evolving global regulatory expectations and industry best practices related to environmental monitoring, aseptic processing, microbial control, cleanroom operations, and contamination control strategy, and translate those expectations into network standards and implementation plans. Qualifications & Experience Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline. Experience Bachelor’s degree in M icrobiology , Biology, Biotechnology, Pharmaceutical Sciences, Engineering, or a related scientific discipline; advanced degree preferred. 10 or more years of relevant experience in biotechnology, biologics, sterile pharmaceutical, or cell therapy manufacturing, with significant experience supporting GMP environmental monitoring, QC microbiology, sterility assurance, contamination control, or aseptic manufacturing operations. Demonstrated experience establishing , harmonizing, or governing environmental monitoring, microbiology, sterility assurance, or contamination control programs across multiple manufacturing sites or a global manufacturing network. 5 or more years of people leadership, program leadership, global process ownership, or cross-functional technical leadership experience in a GMP manufacturing environment. Strong knowledge of global cGMP requirements, aseptic processing expectations, environmental monitoring principles, cleanroom classification, contamination control strategy, microbial control expectations, and risk-based monitoring approaches for sterile biologics or cell therapy manufacturing. </sp