Managing Director and CEO
Pharmalytik
Newark, Delaware
Kim Huynh-Ba is Managing Director of Pharmalytik Consulting, with over 30 years of experience in quality systems, strategic drug development, CMC, and analytical and stability sciences. She currently serves on the USP Biologics Expert Committee (2025–2030) and previously on the USP Council of Experts (2015–2025). She is also a member of the USP Organic Impurities and Supplier Qualification Expert Panels, and serves on the EAS Governing Board of Directors, including as President in 2013.
Kim is an Adjunct Professor at Temple University School of Pharmacy and Illinois Institute of Technology, teaching graduate courses in quality auditing, GMPs, ICH quality guidelines, and pharmaceutical analysis. She serves on the editorial boards of AAPS Open and the Journal of Validation Technology, and is a frequent instructor for ACS, Pittcon, EAS, and PharmaWebinars.
She is editor of Analytical Testing for Pharmaceutical GMP Laboratories and author of two additional books on stability testing. With over 50 publications, she is a recognized speaker at major scientific forums. She was named an AAPS Fellow in 2020 and received the EAS Distinguished Service Award in 2021.
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Regulatory and Compendial Expectations for Analytical Method Lifecycle Management
Wednesday, July 15, 2026
8:05 AM - 8:35 AM East Coast USA Time