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.
Bachelor’s degree in Microbiology, 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.
Demonstrated 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 activities related to environmental monitoring, microbiology, aseptic manufacturing, or contamination control.
Strong technical writing and documentation skills, including experience authoring or reviewing global standards, SOPs, protocols, reports, trend summaries, investigations, risk assessments, governance documents, and inspection responses.
Strong scientific judgment and ability to interpret complex microbiological and environmental monitoring data in the context of product quality risk, site performance, and network-level contamination control signals.
Ability to lead through influence across global Quality, Manufacturing, MS&T, Engineering, Facilities, Validation, Sterility Assurance, site leadership, and external partners.
Excellent communication skills, including the ability to convert technical data into clear executive summaries, network governance narratives, inspection-ready responses, and actionable mitigation plans.
Demonstrated ability to prioritize risk across multiple sites, manage several investigations or program initiatives simultaneously, and drive timely closure of actions in a highly regulated global environment.
High attention to data integrity, documentation quality, compliance detail, standardization, and sustainable global program design.
Continuous improvement mindset with the ability to strengthen systems, harmonize workflows, reduce site-to-site variability, and improve inspection readiness without compromising scientific rigor or local operational needs.
Strong change leadership capability, with the ability to establish new global structures, build stakeholder alignment, and sustain adoption across a complex manufacturing network.
This position requires up to 25% of travel.
M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
Direct experience in cell therapy, gene therapy, biologics drug substance, biologics drug product, aseptic fill/finish, or other sterile manufacturing operations across more than one site or operating model.
Experience with personalized or autologous cell therapy manufacturing, closed and open processing systems, short-cycle manufacturing, high-throughput manufacturing environments, and globally distributed manufacturing networks.
Knowledge of EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, ISO cleanroom standards, and international expectations for risk-based environmental monitoring and contamination control strategy.
Experience designing or deploying global digital EM systems such as MODA, LIMS, electronic batch record interfaces, dashboarding tools, statistical trending platforms, or enterprise data visualization tools.
Experience with microbial identification, bioburden, sterility, endotoxin, mycoplasma, growth promotion, disinfectant efficacy, cleaning validation support, utility monitoring programs, and network-level microbiological control governance.
Experience leading cross-functional and cross-site remediation or mitigation efforts involving HVAC performance, cleaning and disinfection, gowning controls, facility design, personnel practices, process interventions, or contamination control strategy improvements.
Experience influencing senior site and network leadership, aligning multiple sites to common standards, and managing change across diverse regulatory, cultural, and operational environments.
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