Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations

Responsibilities

Team Leadership & Strategy

• Define and execute the Site MSAT function strategy aligned with Cell Therapy Technical Operations to enable development and supply objectives across clinical and commercial stages.
• Build, mentor, and develop a high-performing Site MSAT teams with deep expertise in cell therapy GMP operations and process science and technology.
• Serve as a core member of the site Manufacturing Operations team, contributing to long-range supply planning, risk mitigation, and operational excellence.
• Lead, develop and oversee late-stage and commercial process execution strategies at manufacturing sites to enable harmonization and quality and regulatory compliance.

Development and Manufacturing Interface

• Represent Site MSAT in technology transfer, process validation and commercial supply teams to ensure successful supply of cell therapy products.
• Represent Manufacturing Operations in the CMC team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals).
• Lead Clinical manufacture and PPQ readiness at the manufacturing site that includes material, facility, equipment, manufacturing systems, documentation and process operations readiness.
• Implement and maintain Proactive Process Analysis (PPA) and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites.

Lifecycle Management

• Identify and implement process improvements that improve process robustness, cost of goods, plant throughput, and supply continuity within the boundaries of an approved or cleared clinical products.
• Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.

Regulatory & Quality Support

• Serve as the senior accountable Site MSAT leader for regulatory submissions — Pivotal INDa, BLA, MAA, and supplements — reviewing CMC sections to ensure alignment with the site operations.
• Lead site preparedness and technical support for health authority inspections and audits working closely with Quality and Manufacturing Ops teams.
• Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
• Develop and defend sound scientific justifications for site operations (SOPs, MBRs, Manufacturing systems, Operation trainings), and any site-specific changes to the approved products.
• Lead site-specific Change Controls and ensure timely implementation and compliance working with global MSAT team.

Cross-Functional Partnerships

• Manufacturing Operations – align with site capability and readiness and provide routine support to enable flowless execution at the site
• Quality — ensuring process compliance and product quality standards at the site
• Supply Chain — align and support readiness for supply of the clinical and commercial products
• CMC Leadership — providing site MSAT input for tech transfer, clinical manufacture, process validation and commercial supply
• Governance — participate in Change Controls and Technical Governance Committees

Qualifications

Education

B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.

Experience

• 12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.
• Technical expertise in cell therapy manufacturing processes and technologies is highly desirable.
• Experience in the biologics or viral vectors or vaccines will be considered.
• Extensive background in GMP manufacturing operations, site readiness for clinical manufacture, process validation, and commercial supply, and site support for commercial products.
• Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.