Dr. STU IRWIN

• Bioprocess risk assessments: cell and gene therapies, engineered tissue products and devices.
• Quality system optimizations, and streamlining batch release process.
• Risk mitigation and process improvements / CQI implementation
• Recent partners: Vascudyne Inc., Endsulin Inc., IQVIA, Texas A&M and Quantec Inc.

Rebuild of department, hire and train new staff and gain control of utility and equipment management after several resignatinos (engineer team credibility and relationships, workflow integrations and metrics); optimize HVAC for wet labs and GMP manufacturing areas.

Responsible for Technical Portfolio (22 concurrent international projects) including CRISPR development (CAS9/12 versions) and iPSC/CAR-T lines. Assumed role of team builder and conflict manager between culturally diverse teams in Canada, USA and Austria.

• Hired to start and lead manufacturing team from existing development group through to pivotal studies (7 concurrent clinical trials - now $500M public company - HUMA).
• Responsible for facility, equipment, tech transfer, troubleshooting, and clinical manufacturing of engineered human tissue prosthetics.
• Person-in-plant role at CMO (cross functional role between head office and CMO covering quality, manufacturing, equipment and executive communication.

• Started and operated small CDMO based out of Medical University of South Carolina, Hollings Cancer Center (Faculty role) as Director of QA/RA and hands-on in lab.
• Autologous Islet transplants, gene-modified T-cells, dendritic cell vaccines.

Responsible for GMP re-engineering of stem cell isolation and cryopreservation process to be fully accredited, semi-automated, ISBT 128-compliant, closed (single use) processing system for cord blood.

Develop workflows, system control charts and implement dashboards. Implementation of immediate process improvements and installation of CQI systems including Executive training.