Jobs 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 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.

Perform and document GMP-aligned QC testing on raw materials, in-process, and final cell therapy products. Analyze data, perform peer reviews, investigate aberrant results, inspect and sample raw materials, and support method optimization, transfer, and qualification in collaboration with MSAT and Manufacturing teams.

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.

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 and oversee day-to-day cGMP manufacturing operations for cell and gene therapy programs at a CDMO. Build and manage a high-performing operations team, ensure GMP compliance, partner with QA, MSAT, and Supply Chain, drive continuous improvement, manage scheduling and training, support technology transfers and regulatory inspection readiness, and provide hands-on on-the-floor leadership during manufacturing runs.