Dr. Qi Guan has over 20 years of pharmaceutical research and development experience covering product development, assay development, and contract services. In 2015, she joined MicroConstants China as Director of Laboratory. In this role, Qi is responsible for managing the operation of MicroConstants China’s Laboratory Department, including developing/validating LC/MS/MS and ELISA based methods for PK sample bioanalysis. She is also in charge of regulated PK sample bioanalysis according to USFDA and OECD Good Laboratory Practices (GLP) regulations, ICH Good Clinical Practice (GCP) regulations, and bioanalysis guidelines from USFDA, EMA, and China CFDA.
Prior to joining MicroConstants China, Qi was Research Scientist at MicroConstants San Diego, responsible for Immunoassay method development. Prior to MicroConstants, she served as Senior, Scientist at Vaccine Research and Diabetes Research groups of Pfizer Inc., responsible for various assay development and validation. Prior to Pfizer, she served as Project Manager and Senior Scientist at BD Biosciences, where she developed over 100 ELISA and ELIS POT assays. Qi received her Medical Degree from the West China University for Medical Sciences, Chengdu, Sichuan, People’s Republic of China and received advanced training in Pharmacokinetics, Immunology and Leadership in Biotechnology. Linda Ling has over 16 years of pharmaceutical research and development experience. In 2008, she joined MicroConstants China and is currently the Senior Director of Quality Assurance. In this role, Linda is responsible for managing the operations of MicroConstants China’s Quality Assurance Department, which includes developing, implementing, and maintaining regulatory and quality programs to ensure compliance with USFDA and OECD Good Laboratory Practices (GLP) regulations as well as providing GCP consulting to clinical sites in China.