Jobs at GeneFab

Lead GMP implementation and maturation of cell and gene therapy platform processes, drive technology transfer and CMC strategy, author regulatory CMC content, oversee GMP equipment procurement and manufacturing runs, mentor junior MSAT staff, and manage quality records including deviations, CAPAs, and change controls.

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.

Support GMP QC testing including method transfer, qualification, troubleshooting, investigations, and release/stability testing. Develop and maintain QC SOPs and documentation, lead root-cause analyses, train junior staff, collaborate with MSAT/ASAT/manufacturing, and drive continuous improvement initiatives.