Senior Director, Cell Therapy Manufacturing Network F&E Lead
About The Position
Establish user requirements and facility design standards for cell therapy manufacturing. Develop risk-based contamination control approaches that account for open and closed processing, personnel gowning regimes, environmental monitoring, and the unique biological risks inherent in patient-derived cellular materials. Collaborate with Global Real Estate and Engineering to evaluate network expansion opportunities, providing cell therapy-specific input on site selection criteria, facility requirements, infrastructure needs, and operational considerations. Provide input to and/or lead engineering studies to inform capital investment decisions, site master planning, new technology adoption, or platform changes. Provide input to and participate in the established capital execution governance framework, planning, and reporting. Lead identification and assessment of facility-related risks across existing sites and new-build programs, including single points of failure in critical utilities, environmental control gaps, safety, and infrastructure risks, and develop mitigation strategies that inform capital prioritization and operational decisions. Harmonize F&E operating models across existing supply sites by identifying opportunities for standardization, shared processes, common resource models, operating costs, and aligned ways of working; develop a roadmap to bring consistency without disrupting ongoing operations. Support development and deployment of Digital and AI solutions for Facilities & Engineering across the supply network. Support implementation of new technology for existing F&E site teams, including training, resource planning, and adoption playbooks. Support SHE management review based on data inputs from the supply sites; identify trends, compliance gaps, and improvement opportunities across the network. Provide input to cell therapy-specific sustainability initiatives aligned with corporate strategy.
Requirements
- Bachelor’s degree in engineering (Mechanical, Chemical, Civil/Structural, or Architectural Engineering)
- Minimum 10 years in pharmaceutical/biotech facilities engineering
- At least 5 years in a network, multi-site, or above-site role
- Direct experience with cell therapy, biologics, or ATMP manufacturing facility design strongly preferred
- Demonstrated experience developing user requirements and design standards for GMP facilities
- Involvement in greenfield or major expansion programs from conceptual design through operational handover
- Expert knowledge of contamination control strategy for aseptic and cell therapy environments, cleanroom design (ISO classifications), pharmaceutical HVAC systems, GMP facility requirements, Engineering Studies, and commissioning/qualification protocols
- Familiarity with sustainability frameworks and current regulatory expectations for cell therapy facility design
- Engineering judgment
- Contamination control risk assessment
- Ability to develop standards and requirements
- Cross-functional collaboration
- Stakeholder influence across sites
- Ability to translate manufacturing operational needs into facility design requirements
- Comfortable operating in a support and input role within matrixed governance structures
- Familiarity with BIM (Building Information Modeling)
- Familiarity with CMMS (Computerized Maintenance Management Systems)
- Familiarity with environmental monitoring systems
- Familiarity with energy management platforms
Nice To Haves
- Master's degree preferred
- Professional engineering licensure (PE/CEng) desirable
Responsibilities
- Establish user requirements and facility design standards for cell therapy manufacturing
- Develop risk-based contamination control approaches
- Collaborate with Global Real Estate and Engineering to evaluate network expansion opportunities
- Provide cell therapy-specific input on site selection criteria, facility requirements, infrastructure needs, and operational considerations
- Provide input to and/or lead engineering studies
- Provide input to and participate in the established capital execution governance framework
- Lead identification and assessment of facility-related risks
- Develop mitigation strategies that inform capital prioritization and operational decisions
- Harmonize F&E operating models across existing supply sites
- Develop a roadmap to bring consistency without disrupting ongoing operations
- Support development and deployment of Digital and AI solutions for Facilities & Engineering
- Support implementation of new technology for existing F&E site teams
- Support SHE management review based on data inputs from the supply sites
- Provide input to cell therapy specific sustainability initiatives aligned with corporate strategy
Benefits
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health coverage
- Dental coverage
- Vision coverage
- Eligibility for multiple incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
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What This Job Offers
Job Type
Full-time
Career Level
Director
