Timothy I. Mitchell, M.S.

Timothy I. Mitchell, M.S.

Vice President, Quality

Tim Mitchell is Vice President of Quality of Castle Creek Biosciences, Inc.  Mr. Mitchell has more than 40 years of experience leading quality assurance and control, regulatory affairs, global compliance, validation, aseptic facility engineering, and site management for companies focused on human gene and cell therapy, human stem cell therapy, immunobiologics, and recombinant, large molecule technologies.  

Working directly with global regulatory authorities, including the U.S. Food and Drug Administration (CDER, CBER, ORA), European Union (EMEA, MHRA), Japan (PMDA), Health Canada, Australia (TGA), and China (CFDA), Mr. Mitchell has informed IND, BLA, and NDA submissions, pre-approval inspections (PAI’s), and post-approval (commercialization) GMP inspections. His expertise extends to establishing and managing CMC regulatory documentation, as well as operational and quality/compliance programs and systems that support new manufacturing facilities for both large-scale commercial and pilot-scale clinical production of sterile human cells, biologics, and protein-based pharmaceuticals to comply with global GMP regulations.  

Prior to joining Castle Creek, Mr. Mitchell served as Vice President of Quality for Askbio Biopharmaceutical, Innovative Cellular Therapeutics, Endocyte, Inc. (Novartis), and Cognate Bioservices, Inc.  He earned his M.S. in genetic biology from Purdue University.