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Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)

Sr. CMC Consultant
CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
Marina del Rey, California

Michelle Tseng, Ph.D.(candidate), SCYM(ASCP)CM is a seasoned CMC and Quality leader with 18 years in biopharmaceuticals, specializing in analytical development and team leadership. Currently completing a Ph.D. in Business Data Analytics at Grand Canyon University (expected completion in December 2025), her dissertation optimizes CMC strategies using data analytics. She holds a B.Sc. in Biology and Chemistry from Carlow University and an M.Sc. in Biology from Fairleigh Dickinson University, grounding her extensive expertise.

Michelle has advanced biologics—monoclonal antibodies, ADCs, cell/gene therapies, mRNA vaccines, and tissue therapeutics—from early development to commercialization, contributing to approvals like Keytruda, Yescarta, Tecartus, Lifileucel, and Januvia. Her career includes roles at Biologics Consulting Group, Azzur Labs, ImmPACT Bio, GraphiteBio, Iovance, Kite, Roche, and Merck, where she led method validation (HPLC, flow cytometry, ddPCR), stability programs, and tech transfers, ensuring GMP/GLP compliance with FDA, EMA, USP/ChP, and ICH guidelines. She holds two U.S. provisional patents in flow cytometry and has authored 15+ publications, including a book chapter on immunomodulatory biologics.

Disclosure information not submitted.

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