He joined FDA as a review chemist in Center for Drug Evaluation and Research (CDER) in 1998. His responsibilities in FDA CDER include reviewing, evaluating, and writing technical reviews on the Chemistry, Manufacturing and Controls (CMC) sections of New Drug applications (NDA), Investigational New Drug (IND) and Post-approval Chemistry Supplements. In 2004, he moved to FDA CDER Office of Compliance, Investigational and Pre-Approval Branch as a compliance officer, responsible for compliance review on CGMP compliance of drug substance and drug product manufacturing facilities, as well as participating preapproval and GMP inspections.
Dr. Gu has authored/co-authored over 50 peer reviewed scientific papers, patents and abstracts, and provide numerous invited presentations and lectures on CMC related subjects. He has received numerous awards from FDA, including FDA Commissioner’s Special Citation for extraordinary achievements. Since 2011, Dr. Gu has been working as an independent consultant on CMC and CGMP for pharmaceutical industry, and he has successfully helped numerous clients passing GMP inspections on API, OSD and sterile injection manufacturing facilities and received approvals of their drug applications from US FDA.