WuXi Biologics (WuXi Bio, 02269.HK), a global open-access biologics technology platform company, offering end-to-end solutions for biologics discovery, development and manufacturing, has named Dr Chiang Syin as its new chief quality officer, it was reported yesterday.

Dr Syin will be responsible for quality assurance, quality control laboratories and regulatory affairs.

He has around 30 years of experience in FDA regulatory review and GMP compliance of biological and biotech products. Prior to joining WuXi Biologics, he was a Gates Project International Expert for the CFDA's Center for Food and Drug Inspection. From 2012 to February 2017, 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. He was briefly transferred to the Center for Drug Evaluation and Research (CDER) with biotech products in 2003 to help set up the biotech inspection team in CDER. He joined CBER in 1988 after his postdoctoral training in NIAID (National Institute of Allergy and Infectious Diseases), NIH (National Institutes of Health) and performed regulatory reviews for IND (Investigational New Drug) and BLA (Biologics License Application) in addition to malaria research. From 1988 to 2012, he worked in the Offices of Vaccines, Blood and Compliance in CBER.