Michael Sadick Email & Phone Number

Senior Director and Research Scientist with 35+ years of experience leading analytical and CMC teams supporting biopharmaceutics and cell/gene therapeutics. Extensive experience in oversight, development, pre-validation, phase-appropriate validation, transfer and submission of cell-based (relative potency) assays, immunoreactivity assays, molecular biology and physiochemical analyses. Active within the industry (biopharmaceutical and cell/gene therapy) establishing guidelines for and use of relative potency assay approaches. Strong collaborator with analytical development and process development SMEs, as well as with regulatory, quality, manufacturing and senior leadership. Previously, I worked at Catalent Biologics, both in Morrisville, NC, as a Principal Scientist and, before that, in Kansas City MO as a Senior Manager. In both positions , I led development and support efforts in Bioassays, ELISA, molecular biology, binding kinetics and new technologies, etc. • Prior to that, I worked at Eli Lilly and Co. as a Analytical Development Research Advisor for 6 years. • Before my tenure at Eli Lilly, I worked for 10 years (1991 – 2001) at Genentech in South San Francisco. I have an extensive background in cellular biology, cellular immunology and receptor signaling, molecular biology and biochemistry. I received my MS and Ph.D. in immunology from University of Washington in Seattle, and my BA in biology from Johns Hopkins, in Baltimore.

Listed skills include Assay Development, Elisa, Biotechnology, Cell Biology, and 20 others.