Duane brings 25 years of experience in the highly regulated diagnostic and biopharmaceutical industries to the NOWDiagnostics team. Over the course of his career, he has led teams in development, manufacturing, regulatory, quality, and management during all phases of company development from startup through growth and maturity. His teams have implemented and maintained FDA and ISO compliant systems for manufacturing, quality management, document control, training, and material control. He has extensive experience with inspections and audits by regulatory bodies, qualified persons, notified bodies, clients, and internal audit teams. In his previous posting, Duane directed his manufacturing team through a successful first FDA pre-approval inspection for a novel biopharmaceutical. Duane holds a B. Sc. in Chemical Engineering from the University of Arkansas.