Teams at GeneFab

Execute upstream and downstream cell and gene therapy manufacturing in a GMP cleanroom. Perform aseptic techniques, complete batch records, troubleshoot deviations, support CAPA closure, train staff, and drive 5S/process improvements to ensure timely, right-first-time batch execution while collaborating with Operations, MSAT, Quality, and Facilities.

Lead selection, implementation, and lifecycle management of production technologies and digital systems for GMP cell and gene therapy manufacturing. Act as system owner for critical equipment and computerized systems, ensuring data integrity, connectivity (OPC-UA/APIs), historians, EBR/LIMS integration, CPV enablement, regulatory inspection readiness, and vendor management. Support commissioning, qualification, and commercial readiness activities.

Lead end-to-end CMC programs for cell and gene therapy within an Integrated Project Delivery (IPD) framework. Drive cross-functional alignment (SynBio, PD, AD, MSAT, QC, GMP), manage scope/budget/risk, coordinate regulatory CMC readiness for filings (IND/IMPD/BLA/MAA), facilitate governance and sponsor collaboration, and oversee technology transfers and submission-ready data packages.