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Mike Zdanowski
Executive Operations Leader, Cell and Gene Advanced Therapies
Mike Zdanowski is an accomplished executive leader with over 25 years of experience in FDA CGMP regulated industries. He has a proven track record of success in operations, quality assurance, regulatory affairs, manufacturing, compliance, engineering, and validation for biologic and pharmaceutical products. His areas of expertise include stem cell, MoAB, blood products, liquids, ointments, crèmes, and solid dose medications. Mike holds a Bachelor of Science in Mechanical Engineering from the University of Pennsylvania, an MBA in Finance from Columbia Business School, and a BAS in Philosophy, also from the University of Pennsylvania.
Throughout his career, Mike has held several high-level positions, including his current role as Chief Technology Officer at Talaris Therapeutics. He has also served as the Senior Vice President of Biopharmaceutical Operations at Medeor Therapeutics, Vice President of GMP Operations at The New York Stem Cell Foundation Research Institute, Vice President of Manufacturing at Mesoblast, Ltd., and Director of Operations at the National Cord Blood Program, New York Blood Center.
As an expert in FDA CGMP regulated industries, Mike has a deep understanding of the complex regulatory landscape that governs the development, manufacturing, and distribution of biologic and pharmaceutical products. He brings a wealth of experience to any organization, and his contributions have had a significant impact on the success of the companies he has worked with.