Mike McCormick is the Vice President of Quality and Compliance at The Discovery Labs Center for Breakthrough Medicines. He has over 20 years experience specializing in Quality Assurance, Quality Control, Operations and Regulatory Affairs, within the biotechnology, cell and gene therapy, and pharmaceutical industries with a proven track record of success in maximizing performance, scaling quality commercial operations and streamlining quality systems, while maintaining the highest levels of compliance with global regulations over multi-site operations. Prior to joining, Mike spent seven years as the V.P of Quality Assurance and Regulatory Affairs at WuXi Advanced Therapies and held similar leadership roles supporting the commercial manufacturing of API’s.
Throughout his tenure at WuXi, Mike led the quality and regulatory organizations in support of cell and gene therapy and viral vector operations which supported over 30 client products, over 500 executed batches and was integral in the lot release testing for over 40 commercial products. In addition, Mike had direct oversight of the capacity buildout for manufacturing and testing operations, expanding the site capacity from 82,000 square feet to over 400,000 square feet.
While leading the Quality and Regulatory Programs for Cell and Gene Therapy, Viral Vector, and Commercial Lot Release for Biological Products, Mike successfully represented Site Operations and Quality programs during inspections from global regulatory agencies resulting in successful outcomes: GMP Certificates (EMA and TGA,(3)), Marketing Authorization Approval (MAA) in Japan (PMDA), Korean FDA Inspections (KFDA, (2)) and successful outcomes of multiple FDA inspections (3).
The GMP programs inspected supported the following manufacturing products: Viral Vector Products (11), Gene Mediated Cell Therapy Products (8), and Cell Therapy Products (12).
Mike has his MBA with an emphasis in Biotechnology and Health Industry from Penn State University and attended the University of the Sciences in Philadelphia where his field of study was Pharmacology and Toxicology.