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

• Define and execute the Site MSAT function strategy aligned with Cel l Therapy Technical Operations to enable development and supply objectives across clinical and commercial stages.

• Build, mentor, and develop a high -performing Site MSAT team s 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 .

• 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 .

• I mplement 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

• 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.

• Serve as the senior accountable Site MSAT leader for regulatory submissions — Pivotal IND a , 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 (SOP s , MBRs, Manufacturing systems, Operation training s) , and any site-specific changes to the a pproved products.

• Lead site-specific Change Controls and ensure timely implementation and compliance working with global MSAT team .

You will work in close partnership with:

• 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

• C MC Leadership — providing site MSAT input for tech transfer, clinical manufacture, process validation and commercial supply

• Governance — participat e in C hange Controls and Technical Governance Committees

• 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.

• 1 2 + 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 suppl y, and site support for commercial products .

• Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.

The annual base pay for this position ranges from $ 216,996.00 - $325,494.00 . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.