Senior Research Scientist
US FDA
St. Louis, Missouri
Jingyue (Jan) Yang is a Sr. Research Scientist in the Office of Pharmaceutical Research (OPQR), Office of Pharmaceutical Quality (OPQ) at the FDA’s Center for Drug Evaluation and Research (CDER). In her various roles, Jan develops and applies analytical methods to assess the quality of pharmaceutical products and to investigate adverse events associated with medical product use. She also performs research to improve the characterization and understanding of complex drug substances and products to support generic drug assessment and approval. Jan has been a key team member to provide analytical support to the FDA’s task force for the investigation of nitrosamine contamination in the past few years. She has developed analytical methods to detect and quantitate various nitrosamines in pharmaceutical products and is currently conducting research to study the prevalence of nitrosamine contamination in pharmaceuticals and to investigate risk mitigation strategies. Jan earned her B.Sc. in chemistry from Beijing University in China and received her PhD in chemistry from Washington University, Saint Louis, MO. She was a postdoctoral researcher in biomedical research and worked as an analytical chemist at a pharmaceutical company prior to joining FDA in 2014.
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Navigating the Complexity of LC-MS Method Development for NDSRI Analysis - Case Studies
Tuesday, July 23, 2024
9:35 AM – 10:05 AM CST
Nitrosamine Analysis and Control Panel Discussion
Tuesday, July 23, 2024
10:55 AM – 11:25 AM CST