Guolan Wei, Associate Director & Site Lead, Bioanalytical Services
Guolan Wei has more than 20 years of experience in contract research organizations and biotechnology companies. She has expertise in regulated bioanalysis with LC-MS/MS assays and immunoassays (PK, ADA, neutralizing antibodies and biomarkers).
Guolan has extensive experience in GLP/GCP bioanalysis for both small and large molecules. She managed more than 100 preclinical and clinical studies as principal investigator and contributed to numerous IND and NDA filings. She has rich experiences in hosting international regulatory inspections including FDA, OECD and NMPA.
She led the study team to pass more than 20 on-site China FDA inspections. Additionally, more than 10 products she supported were approved for China's market. She has also served as lab operation lead to lead laboratory operations, manage resources and drive process optimization. Guolan received an MS in biological sciences in 2001.