Heath Coats

Heath Coats

Heath Coats

Heath has over 25 years of industry and consulting experience in parenterals and biologics. He previously worked for seven years as a Biologist with the Division of Manufacturing and Product Quality (DMPQ) in CBER, gaining extensive knowledge of administrative and regulatory review procedures for INDs and CMC sections of biologics license applications. While at the Agency, Heath reviewed applications and supplements for cell therapy products, HPC cord blood, plasma fractionated products, vaccines, allergenics, and in vitro diagnostics.

Heath performed and led numerous pre-license and pre-approval inspections while a member of DMPQ. Heath would also routinely participate in pre-submission meetings with sponsors in order to evaluate facility design, operation, manufacturing
and testing procedures, and compliance with Good Manufacturing Practices.

Work experience

Prior to his tenure at FDA, Heath was a hands-on manager of the validation program for eight years at a cell therapy contract manufacturing company that also manufactured endotoxin detection products and cell culture media. His department
was responsible for all validation activities at the site including facility, equipment, computer, process, and cleaning. His department documented, investigated, and facilitated corrective actions for deviations when encountered. Heath and his department also participated in factory acceptance testing of capital equipment, statement of work generation for cell therapy clients, and customer and Agency audits as facility and technical subject matter experts.

Heath also has over ten years hands on industrial experience in manufacture of biologically active proteins. This experience includes protein expression through fermentation, protein purification and quality control testing. Heath’s responsibilities included development and optimization of procedures and then creating accompanying procedures and batch records.

Education

He holds a BS in Biology from Mount St. Mary’s University and an MS in Biomedical Science from Hood College.
 

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