Michelle Tseng

Michelle Tseng, Ph.D. (Candidate), SCYM(ASCP)CM is an accomplished CMC and Quality leader with 18 years of biopharmaceutical experience, guiding viral and non-viral gene and cell therapies, small molecules, oligonucleotides, biologics, and drug–device combination products from discovery to commercialization. She has supported the development of over 30+ viral CGT and 6 non-viral AAV therapeutics, 6+ small-molecule programs, and 10+ biologics and drug-led medical device programs across multiple clinical phases. Her expertise spans analytical development, QC, method validation, statistical trending (JMP, Prism, R), stability programs, and tech transfer, ensuring inspection-ready CMC and Quality systems for global regulatory submissions. Michelle has held key roles at Merck, Roche, Kite/Gilead Sciences, Iovance, Graphite Bio, ImmPACT Bio/Lyell, Azzur Labs, and Biologics Consulting, contributing to major approvals including Keytruda, Yescarta, Tecartus, Lifileucel, Rituximab, and Januvia. Certified in Flow Cytometry (ASCP) and completing her Ph.D. in Business Data Analytics at Grand Canyon University (defending Dec 2025), she integrates scientific, quality, and data-driven strategies to deliver compliant, scalable, and efficient CMC solutions. Michelle has authored 20+ peer-reviewed publications and a book chapter on immunomodulatory biologics.