Jobs at GeneFab

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.

Lead all controllership functions for U.S. and Taiwan entities: GL, month/quarter close, consolidations, GAAP financials, AP and cash management, audits, tax compliance, payroll/equity administration, ERP implementation, internal controls and IPO-readiness. Hands-on leader executing core accounting while managing a small internal team and external advisors in a cGMP biopharma CDMO environment.

Support QC Microbiology by performing environmental monitoring in controlled manufacturing areas: surface and air sampling, non-viable particle monitoring, sample handling, accurate GMP documentation, basic incubation/reading tasks, equipment upkeep coordination, and adherence to cleanroom gowning and contamination control. Weekend availability required.

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.

Lead CRDMO programs across the full CMC lifecycle within an Integrated Project Delivery model. Drive cross-functional alignment (SynBio, PD, AD, MSAT, QC, GMP), manage regulatory CMC readiness for IND/BLA/MAA/IMPD, oversee budgets, risks, and governance, and serve as primary sponsor contact while enabling knowledge and technology transfer and ensuring data integrity and compliance.

Perform detailed GMP data review of analytical and microbiological results, lead laboratory investigations (OOS/OOT/deviations), manage CAPAs, support batch disposition and documentation, and collaborate cross-functionally to ensure data integrity and regulatory compliance in a Cell & Gene Therapy QC environment.

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.

Provide legal counsel for drafting, reviewing, and negotiating commercial and operational agreements (MSAs, SOWs, NDAs, MTAs) in a CDMO context. Align contracts with Quality/Regulatory teams, protect IP and capacity, manage contract lifecycle, and maintain templates and playbooks to streamline sales and operations while ensuring cGMP and data integrity compliance.