Michael Kuo
Michael Kuo is a board certified Medical Technologist with over 20 years of experience in cell therapy and tissue engineering manufacturing, biopharmaceutical QC analytical testing, Quality Assurance/Quality Systems.
He has a comprehensive background in GMP, GLP, ISO standards, and has managed successful teams to ensure operational efficiency and high-quality standards.
Michael excels in GMP manufacturing facility and GLP laboratory design, build-out, and qualifications, as well as in authoring and reviewing regulatory submission documents.
His specialties include technical expertise in laboratory medicine, quality assurance, regulatory affairs, assay development, facility design, and management of Technology Transfer and vendors.
Education-wise, he studied a Certification Program in Biomedical Regulatory Affairs and holds double degrees in Medical Technology and Microbiology from the University of Washington.
Michael has held notable positions like VP Quality and Supply Chain at Mana Therapeutics, VP Quality and Operations at MaxCyte, Inc., Senior Director of Quality Assurance at Mesoblast Limited, among others.
His experience ranges from being a Laboratory Manager at Puget Sound Blood Center to a Co-Founder at MD International Laboratory Consulting, Inc.
