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Dr. Syin brings 30 years of experience in FDA regulatory review and GMP compliance of biologics
January 15, 2018
By: Kristin Brooks
Managing Editor, Contract Pharma
Dr. Chiang Syin has been appointed chief quality officer, WuXi Biologics. Dr. Syin is responsible for quality assurance, quality control labs and regulatory affairs. Dr. Chiang Syin has 30 years of experience in FDA regulatory review and GMP compliance of biologic products. Prior to joining the company, he was a Gates Project International Expert for the Center for Food and Drug Inspection of CFDA (CFDI). Earlier, he served as the FDA Associate Country Director managing the Office’s drug and device inspection program in China. Prior to joining the China Office, he served as a Branch Chief in the Office of Compliance and Biologics Quality, the Center for Biologics Evaluation and Research (CBER). In this position, he provided leadership and program guidance to the staff engaged in Chemistry, Manufacturing and Control (CMC) reviews and GMP inspections for premarketing license applications and post marketing changes of the biological products. Dr. Syin has been actively involved in FDA drug/biologics regulatory policy and guidance development that includes drafting Vaccines CMC and Phase I GMP guidance documents as well as the 2011 Process Validation guidance revision. “We are very pleased to welcome Dr. Syin to WuXi Bio where his leadership can bring our quality and regulatory organization to a new level,” said Dr. Chris Chen, chief executive officer of WuXi Biologics, “Dr. Syin’s nearly 30 years of experience at U.S. FDA and CFDA (China Food and Drug Administration) biologics quality and compliance will accelerate our path to build a world-class quality organization for biologics commercial manufacturing.”
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