Alice Yee
About Alice Yee
Alice Yee serves as the Head of Quality Control at Sana Biotechnology, Inc., where she has worked since 2020. She holds a Ph.D. in Kinesiology from the University of Southern California and has extensive experience in quality control and regulatory compliance in the biotechnology sector.
Work at Sana Biotechnology
Alice Yee serves as the Head of Quality Control at Sana Biotechnology, Inc. since 2020. In this role, she oversees quality control operations and ensures compliance with regulatory standards. Her leadership has contributed to the successful support of programs, including one that received FDA approval ahead of schedule. Her work is based in South San Francisco, California, where she applies her extensive experience in quality management to enhance operational efficiency.
Education and Expertise
Alice Yee holds a Ph.D. in Kinesiology from the University of Southern California and a Master’s degree in Kinesiology from San Francisco State University. She also earned a Bachelor of Arts in Economics from Occidental College. Her educational background provides a strong foundation for her expertise in quality control and regulatory compliance in the biotechnology sector.
Background
Prior to her current position, Alice Yee accumulated significant experience in the biotechnology and healthcare industries. She worked at Genentech in various roles, including Senior Quality Product Leader and QC Scientist, from 2006 to 2020. Additionally, she served as a QC Supervisor at Bio-Rad Laboratories and as a Senior Scientist III at Abbott Healthcare. This diverse background has equipped her with a comprehensive understanding of quality control processes.
Achievements
Alice Yee has demonstrated a strong capability in regulatory submissions and quality control processes. She successfully supported a program that achieved FDA approval two months ahead of the PDUFA date, with minimal information requests. Her proficiency includes writing standard operating procedures (SOPs), work instructions (WIs), and protocols in a GMP Quality Control environment, showcasing her commitment to maintaining high-quality standards.
Regulatory Knowledge and Skills
Alice Yee possesses a deep understanding of regulatory submission requirements, including PMPs, CBE's, IND, and Q&A. She demonstrates excellent knowledge of ICH guidelines and compendia requirements such as USP, EU, and JP. Her skills in analytical method troubleshooting, redevelopment, validation, and lifecycle management further enhance her effectiveness in quality control roles.