Biography:

Kim Huynh-Ba has over 30 years of experience in quality systems, analytical development, project management, strategic drug development, and stability sciences. She currently is the managing director and CEO of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She also has provided support to build Quality Management Systems (QMS) for many clients in the US and abroad. From 2011-2013, she took a sabbatical from Pharmalytik to join the U.S. Pharmacopeia (USP) Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb, and Wyeth Vaccines.

Kim is also a short course instructor on numerous cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT) teaching Quality Audit, Analytical chemistry, Good Manufacturing Practices and ICH Quality Guidelines for their regulatory and compliance graduate programs.

Kim was named a Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2022 and chairs the CMC Community. Kim received the Distinguished Board Member award of the Eastern Analytical Symposium (EAS) and was their 2013 President. She is a Council of Experts of US Pharmacopeia (cycle 2015-2025), chairing Chemical Medicines IV Expert Committee. She was also the Chair of the USP Good Documentation Practices Expert Panel and a member of the USP Impurities of Drug Products Expert Panel. Kim co-chaired the organization and the development of the Regulatory Sciences 101 and Stability 101 eLearning courses for AAPS launched in 2014 and 2015.

Kim has authored over 80 technical publications and book chapters and has spoken extensively, both domestic and internationally, about the compliance and quality areas. Kim is a member of the Editorial Board of AAPS Open Access Journal and International Validation Technology (IVT). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008), “Pharmaceutical Stability Testing to Support Global Markets” (2010), and recently published the "Analytical Testing for the Pharmaceutical GMP Laboratory" (2022). Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. Kim is a member of the Editorial Board of AAPS Open Access Journal. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).