Ziqi Gui
Sr Director @Vaxcyte
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WORK HISTORY
Sr Director @Vaxcyte
San Carlos, CA, US
EDUCATION
Western University (Canada)
Ph.D., Chemistry
SKILLS
ABOUT ZIQI GUI
Progressive management experience in pharmaceutical and medical devices. Strong leadership and management skills in Analytical Development, Product Development, and Laboratory Operations; Extensive experience in team building, conflict resolution, and motivation; Solid experience in CMC preparations for IND, NDA/ANDA fillings in pharmaceutical industry and working knowledge in IDE/CE/PMA submissions for DES (drug eluting stents) in medical devices; Thorough understanding and knowledge of cGMP, FDA/ICH/USP regulations and stardards; Technical expertise in analytical method development/validation/transfer, Stability programs, and specification development in drug substances and drug products. Exceptional trouble-shooting abilities in analytical chemistry; Excellent interpersonal and communication skills, diligent and efficient, thinking broadly, and capable of making difficult decisionsSpecialties: cGMP, ICH/FDA Guidelines; CMC preparations; Analytical method development and validation; Specification development in raw materials, in-process, and finished products; Stability program; Cleaning validation; Clinical release; Laboratory Operations, including management of lab cost reduction, turn-around-time, OOS/OOT investigations, CAPA activities, and other key compliance performance indicators
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