Teams 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.