Associate Director, Environmental Monitoring Program Coordination

Bristol Myers Squibb

. Establish and lead the global governance model for Environmental Monitoring across biologics and cell therapy manufacturing sites .

Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesSenior💰 $157,880 - $204,702 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Environmental Monitoring governance, including the establishment of standards, procedures, and data review processes across biologics and cell therapy manufacturing. Proficient in risk assessment, contamination control, and regulatory compliance within a GMP environment.

Highest-signal resume keywords

Environmental Monitoring GovernanceGMP Environmental MonitoringCross-Site Data EvaluationRegulatory Inspection SupportContamination Control Strategy

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Hard Skills

MicrobiologyEnvironmental MonitoringData TrendingRisk AssessmentCAPA DevelopmentDeviation InvestigationAseptic ProcessingCleanroom ClassificationTechnical WritingScientific Judgment

Soft Skills

LeadershipChange LeadershipInfluenceAttention to DetailPrioritization

Tools & Technologies

LIMSMODA PlatformsElectronic Trending ToolsDashboardsData Standards

Industry Keywords

BiotechnologyBiologicsCell Therapy ManufacturingSterile PharmaceuticalGMPContamination ControlMicrobial ControlInspection ReadinessAseptic Fill/FinishDigital EM Systems

About the role

Key responsibilities & impact

Establish and lead the global governance model for Environmental Monitoring across biologics and cell therapy manufacturing sites
Define harmonized EM standards, procedures, sampling strategies, monitoring frequencies, limits, escalation pathways, and data review processes
Lead network-level EM data trending and governance, including cross-site comparisons and systemic signal identification
Develop a global approach for trend evaluation, excursion categorization, impact assessment, mitigation planning, CAPA linkage, and effectiveness monitoring
Translate EM signals into risk assessments, mitigation plans, contamination-control improvements, and governance decisions
Coordinate cross-site responses to significant or recurring EM excursions
Serve as global environmental monitoring subject matter expert during investigations, contamination events, facility start-up, transfers, product introductions, readiness reviews, and inspections
Ensure site EM programs align with global Contamination Control Strategy and aseptic, qualification, cleaning, gowning, and process-risk expectations
Partner with sites to evaluate environmental signals against operations, flows, interventions, cleaning, HVAC, maintenance, and process design
Lead global EM trend review boards, contamination control councils, escalation meetings, and network health reviews
Establish metrics and dashboards for EM program health, excursion rates, investigations, CAPA effectiveness, recurrence, and inspection readiness
Support regulatory inspections and internal audits by presenting the global EM program and governance approach
Provide leadership, coaching, and technical guidance to QC microbiology, EM coordination, Quality, and cross-functional stakeholders
Evaluate and implement global digital EM systems, LIMS/MODA platforms, electronic trending tools, dashboards, data standards, and integrity controls
Support network expansion, product introduction, technology transfer, facility modification, process changes, and validation activities
Monitor evolving regulatory expectations and industry best practices and translate them into network standards

Requirements

What you’ll need

Required B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
10 or more years of relevant experience in biotechnology, biologics, sterile pharmaceutical, or cell therapy manufacturing
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, environmental monitoring, cleanroom classification, contamination control strategy, microbial control, and risk-based monitoring
Experience with EM data trending, cross-site data evaluation, excursion management, deviation investigations, CAPA development, root cause analysis, risk assessment, and effectiveness verification
Experience supporting regulatory inspections, internal audits, health authority interactions, or global inspection readiness
Strong technical writing and documentation skills
Strong scientific judgment interpreting microbiological and environmental monitoring data
Ability to lead through influence across global Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, Sterility Assurance, site leadership, and external partners
Ability to prioritize risk across multiple sites and manage multiple investigations or initiatives
High attention to data integrity, documentation quality, compliance, standardization, and global program design
Strong change leadership capability
Ability to travel up to 25%
Advanced degree preferred
Preferred experience in cell therapy, gene therapy, biologics, aseptic fill/finish, sterile manufacturing, digital EM systems, microbial identification, bioburden, sterility, endotoxin, mycoplasma, and related contamination-control activities

Benefits

Comp & perks

Comprehensive wellbeing support, retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays annually
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing support for people with disabilities