Tim Mitchell
Vice President, Quality and Regulatory Compliance
Tim Mitchell has more than 27 years of experience in the pharmaceutical, biotechnology, and medical device industries, with extensive involvement and oversight in quality, compliance, regulatory affairs, validation, and manufacturing operations. During his career, Mitchell has acquired in-depth knowledge of aseptic and sterile processing with a primary focus on global compliance assessment and management through facility design and operational GMP control of both bulk API and final product manufacturing.
Mitchell has had direct management responsibilities in support of 19 new GMP manufacturing facilities worth more than $5.3 billion, 17 of these new facilities being sterile/aseptic manufacturing facilities. He has established and managed operational and quality/compliance programs and systems to support these facilities, which were built for both large-scale commercial and pilot-scale clinical production of sterile human biologic and chemical pharmaceuticals in compliance with all applicable FDA regulations.
Before coming to UK, Mitchell served as vice president of quality and regulatory affairs at Intranasal Therapeutics Inc. and vice president of quality assurance and regulatory affairs for LifeNet, Inc. Past work experience includes Eastman Fine Chemicals, NABI Biopharmaceuticals, and Eli Lilly & Company.
Mitchell is a graduate of Purdue University's Department of Biological Sciences where he earned his bachelor's degree in genetic biology.