Michael Zdanowski

Vice President, GMP Operations

Bio

As the Vice President of GMP Operations at NYSCF, Mike will lead the GMP Cell production effort including process development, quality and regulatory compliance, and manufacturing. Mike has over 25 years of experience in FDA-regulated industries, with expertise in GMP manufacturing and CMC development including sterile liquids/powders, solid/liquid oral dose, biotechnology, blood products and cell therapy. Along with international consulting experience in GMP compliance, tech transfer, design, construction, validation, startup, and operations for such firms as Pfizer, Bayer, MedImmune, Regeneron and Biogen, Mike has spent the last 10 years working in cellular therapy as Director of Operations and Vice President of Manufacturing for the NY Blood Center (NYBC) and Mesoblast, respectively. For the NYBC, he submitted the first approved Biologics License Application(BLA) for an Allogeneic Stem Cell Product, and for Mesoblast, he oversaw contract manufacturing for Phase II/III clinical trial materials.