Qiong Guo

Director, Analytical Development & Quality Control @Moderna

Lead deviation/OOS/OOT/OOE investigations to support clinical and commercial product lot CoA generation, release and disposition. Contribute to BLA regulatory filings for Moderna COVID-19 mRNA-encapsulated lipid nanoparticle (LNP) vaccines. Support Regulatory Agency pre-approval inspections. Lead overall analytical control strategy including analytical method qualification/validation, IPC/release testing and stability study designs for DS and DP (mRNA and LNPs) to support initial GMP manufacturing, PPQ and commercialization for COVID-19 vaccines. Oversee analytical method development and pre-qualification and lead analytical method tech transfer to internal QC and external CMOs/CROs and method qualification for mRNA and LNPs to enable program advancement to Phase 1/2/3 clinical development. Lead data trending to support specification establishment. Support critical non-GMP and GMP analytical and process related investigations. Drive proposal, alignment and implementation of reference material control strategy for both CMV and COVID-19 late phase vaccine programs. Author CMC sections to support IND regulatory filings for various early phase mRNA-encapsulated LNP vaccine, oncology and rare disease program clinical development.