| Qin joined Lilly Global Regulatory Affairs CMC team in April 2020 to provide strategic, tactical and operational direction to expedite CMC development of Lilly’s portfolio in China. She is recognized for her broad knowledge of China CMC regulatory requirements and technical guidelines, as well as the systematic development of complex China CMC regulatory strategies to warrant clinical trial, market registration and post approval submissions. Qin earned her Masters of Science in Microbiology and Molecular Genetics from University of Texas - McGovern Medical School and Pharmaceutical Science from China Pharmaceutical University, Nanjing. She started her Lilly tenure as a discovery biologist in 1999 working on in vitro assay development and high through-put screening to enable the discovery of a new class of anti-bacterial compounds. From 2002 to 2020, Qin took the responsibility of analytical lead at Lilly Bioproduct Research and Development establishing analytical control strategies for a number of early and late-stage biological products including antibodies, fusion proteins and peptides. |