WUXI, China, Jan. 15, 2018 /PRNewswire/ -- WuXi Biologics (WuXi Bio, 02269.HK), a leading global open-access biologics technology platform company, offering end-to-end solutions for biologics discovery, development and manufacturing, is pleased to announce that Dr. Chiang Syin has joined WuXi Bio as Chief Quality Officer, responsible for quality assurance, quality control laboratories and regulatory affairs.
"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 US 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."
"I am very pleased to join this fast-growing organization that is accelerating and transforming how biologics are discovered, developed and manufactured globally. I look forward to working with the team to continue to improve our quality system and build a premier quality organization to serve the global partners and benefit global patients," commented Dr. Syin.
Dr. Chiang Syin has nearly 30 years of experience in FDA regulatory review and GMP (Good Manufacturing Practice) compliance of biological and biotech products. Prior to joining WuXi Biologics, he was a Gates Project International Expert for the Center for Food and Drug Inspection of CFDA (CFDI). 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 setting 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 of 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.
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.
About WuXi Biologics
WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit www.wuxibiologics.com.