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 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.