Owner, TCubed Regulatory Consulting, LLC, performing Biologics focused consulting services for pharmaceutical manufacturing/CGMP compliance.
Previously, sixteen years FDA regulatory review, inspection, and project management experience in both the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, to include management experience in the Center for Biologics (Team Leader), Office of Compliance and Product Quality, Division of Manufacturing and Product Quality. The latter experience covers all aspects of CGMP, facilities, equipment review, and inspections for products regulated by the Center for Biologics. Service included duties as the final secondary reviewer for all memoranda generated by Branch Review Staff. Was the recognized senior subject matter expert for several functional review areas, to include container closure integrity, aseptic processing, environmental monitoring, lyophilization validation, and cleaning validation. Participated in 20 Pre-Approval inspections, and was the lead inspector for 15 of these. The various positions included working with nearly all major pharmaceutical manufacturers, and numerous minor firms. Previous experience in vaccine/molecular biology based research at the United States Army Research Institute of Infectious Diseases.