Joe Ninosky

Joe Ninosky is a 25-year veteran in the life sciences arena, with extensive experience in all aspects of CMC, including drug substance and drug product development, scale-up, tech transfer, and GMP manufacturing. Raised from the bench and evolving to the board room, Joe has held positions of increasing responsibility at small to mid-size biotech companies ultimately reaching the point where he leads departments and programs as the effective VP of CMC, representing and overseeing all CMC functions (Process Development, Analytical Development, GMP Manufacturing, Regulatory Submissions)

for programs at Phase 1 through commercial launch.

‍

Joe also has a deep understanding of the GMP, Quality, and Regulatory arenas, and often serves as the CMC subject matter expert when interfacing with regulatory agencies during audits and submissions. Joe's most recent oncology experience was as the VP of CMC for Biothery.

‍

Joe holds a BS in Chemical Engineering from the University of California at San Diego and an MS in Chemical Engineering from Oregon State University.