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

MSAT Lead/ Head of MSAT, Technical Operations, Cell Therapy Responsibilities Tech Transfer & Process improvement 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 lifecycles from IND, pivotal manufacturing, BLA readiness to commercial and post-approval. Drive continuous process improvement, robustness, and continuous process validation. Manufacturing Strategy and CDMO management 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. Development and Manufacturing Interface 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. Quality, Regulatory & Cross-functional support 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. Requirements and Qualifications 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. #J-18808-Ljbffr Immix Biopharma (Nasdaq: IMMX)