Youngran Ji is a highly skilled quality professional with experience in biologics drug substance production, analytical testing, and cGMP/ICH/FDA/EMA regulations. With strong project management skills and a scientific background, including genomics, bioanalytical chemistry, cell and molecular biology and immunology, Ji has demonstrated expertise in managing tech transfer and site stability study operations with CMO and cross-functional teams. Additionally, she has provided technical and quality systems support for analytical method validation and successfully completed technical transfer projects. Ji is proficient in leading and implementing complex CAPA projects, managing global Microarray (mRNA based) research collaboration and delivering technical and compliance courses to train over 200 quality professionals. Ji's previous roles include Senior Associate I (Sr. Technical Manager) at Roche (Genentech), QC Associate I – II and Senior QC Associate at Genentech and Research Assistant at Stanford University.