MSAT Lead​/Head of MSAT, Technical Operations, Cell Therapy

MSAT Lead/ Head of MSAT, Technical Operations, Cell Therapy

• Work with CMC technical development teams to define tech transfer strategy, tech transfer protocols and ensure seamless tech transfer into external GMP facilities.
• Define and oversee process characterization, process validation, comparability study across multiple sites.
• Provide technical oversight across cell therapy manufacturing life cycles from IND, pivotal manufacturing, BLA readiness to commercial and post-approval.
• Drive continuous process improvement, robustness, and continuous process validation.

• Serve as the primary operations leader overseeing manufacturing execution at CDMO sites.
• Lead governance of contract manufacturing facilities, ensuring strong alignment on performance, quality, and continuous improvement
• Oversee the execution and risk management of manufacturing operations in CDMO.
• Enable site readiness for pivotal trials, pre-approval inspections and commercial launch at CDMO through planning and strong execution.
• Negotiate and manage CDMO agreements.

• Develop process control strategies, identify potential risks of manufacturing process and develop mitigation plans.
• Represent Manufacturing Operations in the cross functional team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals)
• Develop PPQ readiness and PPQ execution technical framework and oversee execution at the manufacturing sites
• Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.

• Contribute to regulatory submissions (IND, BLA/MAA) and represent Manufacturing Operations in inspections and agency interactions.
• Partner closely with Quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
• Develop and defend sound scientific justifications, lead technical investigations for deviation, change control, and CAPA management across internal and external networks.
• Lead MSAT preparedness and technical support for health authority inspections and audits.

• Advanced degree (MS, PhD) in life sciences, engineering, or related field.
• >5 years of hands-on cell therapy process development and manufacturing experience, >3 years of leading tech transfer and MSAT team working experience.
• Experience with multi-site tech transfer, process validation, IND/BLA filings and regulatory interactions.
• Experience managing CDMOs and external manufacturing networks in a GMP environment.
• Experience in process validation, PPQ, CPV, and regulatory submission is strongly preferred.
• Experience in supporting both clinical and commercial supply. Familiarity with advanced therapy supply chains, including traceability and cold chain logistics.