The CMC group is headed by Zheru Zhang, PhD, President, Head of CMC and Manufacturing. Dr.Zhang obtained his PhD in biochemistry from the University of Alberta, Canada, and has more than 20 years of experience in CMC development and quality management in the pharmaceutical industry in the US, Korea and China. Dr. Zhang has extensive experience working with various regulatory authorities, including NMPA, FDA, EMA, MFDS, PMDA and TGA, on the development of biological products. Before joining I-Mab, Dr. Zhang held technical and management positions at Bristol-Myers Squibb and Johnson & Johnson, and also served as Vice President of Celltrion and President of Tasgen. During his pharma tenure, Dr. Zhang led or participated in Investigational New Drug applications for twenty biologics, and six global Biologics License Applications, including for the first biosimilar monoclonal antibody product approved in Europe, Japan and the US. Under the leadership of Dr. Zhang, the CMC organization is structured to include the following: process development function is led by Dr. Junhua Qiao; analytical development function is led by Dr. Xiangping Zhu; project management teams for China and Global portfolios are led by Dr. Charlie Zhang, Dr. Junhua Qiao and Dr. Sheng Yin; quality assurance function is led by Mr. Jack Qin.
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