Senior Director, Cell Therapy Manufacturing Network F&E Lead
About The Position
This role is responsible for establishing user requirements and facility design standards for cell therapy manufacturing. It involves developing risk-based contamination control approaches, collaborating with Global Real Estate and Engineering on network expansion, and providing cell therapy-specific input on site selection and facility requirements. The position also entails leading engineering studies for capital investment decisions, participating in the capital execution governance framework, and identifying/assessing facility-related risks. A key aspect is harmonizing F&E operating models across existing supply sites by promoting standardization and developing a roadmap for consistency. The role supports the development and deployment of Digital and AI solutions for Facilities & Engineering, aids in the implementation of new technology for site teams, and provides input to SHE management reviews and cell therapy-specific sustainability initiatives.
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.
- 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), CMMS (Computerized Maintenance Management Systems), environmental monitoring systems, and energy management platforms.
Nice To Haves
- Master's degree preferred.
- Professional engineering licensure (PE/CEng) desirable.
- Direct experience with cell therapy, biologics, or ATMP manufacturing facility design strongly preferred.
Responsibilities
- Establish user requirements and facility design standards for cell therapy manufacturing.
- Develop risk-based contamination control approaches for cell therapy manufacturing.
- 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.
- 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.
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
