Heath Coats

Heath Coats is a Senior Principal with Dark Horse Consulting Group (DHCG) providing support across multiple service areas including facilities design and quality and compliance to cell and gene therapies (CGT) and tissue engineering products. Since joining DHCG in 2022, Heath has worked with over 100 clients engaged in developing CGT products from the stage of facility design review through inspection preparedness and remediation activities for clients at both the IND and biologics license application (BLA) stages. Heath has almost forty years’ experience in biotechnology through academic, manufacturing, regulatory, and consulting positions. Heath has spent the past seven years in the consulting space assisting clients with FDA inspection preparedness and remediation activities, after a seven-year tenure as a Chemistry, Manufacturing and Control (CMC) facility reviewer and inspector in the FDA/CBER Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing Product Quality (DMPQ). Prior to FDA, Heath oversaw the validation program for a cell therapy contract developer and manufacturing organization (CDMO) for almost a decade.