Huijuan Li is currently the Vice President of Technology Development at Moderna Inc. Dr. Li oversees analytical method development, transfer, qualification, validation and applications to process and product development from discovery through to regulatory filing of mRNA vaccines and therapeutics. Dr. Li played an integral role in the development of SPIKEVAX (COVID-19 Vaccine, mRNA) vaccine.
Prior to joining Moderna, Dr. Li was the director of analytical development within Biologics Discovery (GlycoFi Site) and later in Bioprocess Development, Merck Research Laboratory. Dr. Li oversaw method development, characterization and applications to cell line, process, and product development from early discovery to regulatory filing for all biologic modalities.
Dr. Li has been leading CMC and development teams to work closely with discovery, preclinical and clinical teams for the development of Biologics, mRNA vaccines and therapeutics at all stages, including post-approval technical, strategic support, and life cycle management for biologics and vaccines while working at Merck and Moderna.
Dr. Li and her team have contributed to commercial filings for global approvals of two monoclonal antibodies (KEYTRUDA, ZINPLAVA) and biosimilars (insulin glargine); SPIKEVAX (COVID-19 Vaccine, mRNA) and more than 40 INDs including monoclonal antibodies, Fc-Fusion protein, PEGylated protein and mRNA therapeutics and vaccines.
Huijuan received her BSc and MSc from Lanzhou University, China, and received her PhD from University of Melbourne, Australia. From there, she pursued her postdoctoral studies at McGill University, Montreal, Canada.