Stuart Tinch builds the quality systems that let cell & gene therapies move from bench to bedside — 15+ years from academic research through GMP vector manufacturing to clinical-stage biotech, most recently building the quality function behind Hemogenyx Pharmaceuticals' lead CAR-T program.
See the career pathStuart is a GMP quality and manufacturing leader who has spent his career at the point where cutting-edge cell and gene therapy science becomes a regulated, repeatable, auditable process. He's worked to improve and build quality systems from the ground up at organizations ranging from academic medical centers to publicly traded biopharmaceutical companies.
His work sits at the intersection of GxP compliance, viral vector and cell therapy manufacturing, and organizational leadership — the rare combination that lets a company move a therapy candidate toward the clinic without cutting corners on quality.
He spent nearly a decade at Cincinnati Children's Hospital Medical Center — starting in immunology and genetics research, then moving into the Vector Production Facility, where he progressed from GxP technician to supervisor and performed and managed more than 70 GMP manufacturing batches for academic and pharmaceutical partners. From there he helped build Expression Therapeutics' GMP manufacturing facility from the ground up, then most recently served as Director of GMP Quality Assurance at Hemogenyx Pharmaceuticals, building the quality system that carried their lead CAR-T candidate through IND and into a Phase 1 trial now dosing patients.
Joined with no GMP culture in place and designed a phase-appropriate Quality Management System from scratch — cleanroom qualification (ISO 5/7/8), deviations, CAPAs, change control, batch record review, and staff training — enabling in-house manufacturing and release testing for the company's lead candidate, HEMO-CAR-T. Supported a successful IND submission; the resulting Phase 1 trial (NCT06786533) has since safely dosed three patients.
Led the build-out of Expression's GMP viral vector and cell therapy manufacturing facility — site selection, equipment qualification, and quality systems — while directing multi-state teams (OH, KY, GA, MO, PA) developing lentiviral and AAV manufacturing processes, including a tech transfer of an AAV process to a partner organization in India.
Supervised 5 FTEs across upstream, downstream, and final fill GMP operations — scheduling production, writing and executing batch records and SOPs, and partnering with QA to keep client releases on schedule.
Grew VPF development capacity by 150% and tech-transferred processes for 6 clients into GMP production; co-authored a chapter on 6L-scale vector production in Viral Vectors for Gene Therapy (Springer Protocols). Also managed the Viral Vector Core, cutting R&D vector repeat rates from 20% to 5%.
GxP manufacturing technician supporting vector production operations at the Vector Production Facility.
Immunology and genetics research on the immune system's role in Gaucher disease — work that culminated in a publication in Nature. Ran mouse immunology techniques including MACS cell separation, primary cell culture, genotyping, and lipid/protein analysis.
Designing and running quality systems that hold up under FDA, MHRA, and other global regulatory scrutiny.
Hands-on background running and scaling GMP production of viral vectors and cell-based therapies.
Building quality functions from zero — SOPs, deviation and CAPA systems, batch record review — at growth-stage companies.
Preparing manufacturing operations and documentation for first-in-human trials through commercial launch.
Leading site quality functions and cross-functional teams inside growth-stage, clinical-stage biotechs.
A track record of joining organizations pre-clinical and helping carry them toward regulated, scaled manufacturing.