Teams at GeneFab

Lead weekend QC lab operations for cell and gene therapy products: supervise testing and data review (raw materials, in-process, release, stability), approve results in LIMS, investigate OOS/OOT, support method transfers and validations, manage equipment calibration and inventory, author/revise SOPs, coordinate scheduling, and collaborate cross-functionally to support product release and continuous improvement.

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 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.