Facility

Dr. Stuart Irwin is a multidisciplinary leader in biopharma facilities and engineering, with experience spanning discovery-stage biologics to full-scale industrial manufacturing. As Head of Manufacturing, his responsibilities encompassed Facilities and Equipment, overseeing multiple lab expansions, technological upgrades, and successful FDA inspections. His expertise includes HVAC and controlled environments, backup power systems, equipment management, SCADA and monitoring systems, sterilization equipment, analytics, imaging, and environmental health and safety.

A former operations management consultant for large industrial operations, Dr. Irwin specialized in failure mode and effects analysis (FMEA), uncovering process improvement opportunities, prioritizing risk mitigations, and driving change within regulated environments. Known for his exceptional influence and conflict management skills, he also brings a comprehensive understanding of functional needs across diverse operational areas, making him a versatile and strategic leader in biopharma manufacturing and facility management.