Mike Zdanowski, RHI Drug Manufacturing and CMC Advisor

Biography

Mike Zdanowski joins RHI with more than 25 years in the Pharmaceutical and Biotech industries, 15 years in Cell Therapy including early-late stage clinical, BLA, and commercial launch and production. Prior to RHI, Zdanowski was Senior Vice President of Biopharmaceutical Operations at Meteor Therapeutics, Inc where he was responsible for process development, analytical method development, manufacturing, Quality Control, and general operations. Previously, he was also Vice President of GMP Operations at the New York Stem Cell Foundation where Zdanowski was an executive leader of various projects designed to deliver Phase 1 stem cell therapies to the clinic. From 2007 to 2013, Zdanowski was Director of Operations at the New York Blood Center where he was responsible for the management of a 115 person team, a $20 million human umbilical cord blood stem cell production division. Throughout his career, Zdanowski has gained extensive experience in Program Management, Operations, Manufacturing, Clinical Operations, Process Development, Quality Assurance, and Systems, Quality Control, Regulatory Affairs, Facilities Engineering, Validation and Qualification, Supply Chain, Storage and Distribution, and General Management.