Ying Yu
About Ying Yu
Ying Yu serves as the Senior Director of GMP Quality Assurance at Arcus Biosciences, where he has worked since 2021. He holds a Ph.D. in Organic Chemistry from Emory University and has extensive experience in chemical development and regulatory affairs across various biotechnology companies.
Work at Arcus Biosciences
Ying Yu serves as the Senior Director of GMP Quality Assurance at Arcus Biosciences, a position she has held since 2021. In this role, she oversees quality assurance processes to ensure compliance with Good Manufacturing Practices (GMP). Her responsibilities include maintaining quality standards and implementing quality systems that align with regulatory requirements. Arcus Biosciences is located in Hayward, California, and focuses on developing innovative cancer therapies.
Education and Expertise
Ying Yu earned her Ph.D. in Organic Chemistry from Emory University, where she studied from 1999 to 2004. She also holds a Bachelor of Science (B.S.) degree from Peking University. Her educational background provides a strong foundation for her expertise in chemical development and quality assurance within the pharmaceutical industry.
Background
Ying Yu has extensive experience in the pharmaceutical sector, having worked in various roles across multiple organizations. Prior to her current position, she held significant roles at companies such as Onyx Pharmaceuticals, MyoKardia, and Bristol Myers Squibb. Her career spans over a decade, focusing on chemical development, manufacturing, and quality assurance.
Achievements
Throughout her career, Ying Yu has authored regulatory filings for multiple regions, including New Drug Applications (NDA), Biologics License Applications (BLA), and Investigational New Drug (IND) submissions. She has led cross-functional teams that include formulation, analytical, quality, supply chain, and regulatory groups, demonstrating her ability to manage complex projects in the pharmaceutical industry.
Professional Experience
Ying Yu has held various leadership positions in the pharmaceutical industry. She worked as a Senior Manager in Chemical Development at Onyx Pharmaceuticals from 2008 to 2015, followed by roles at MyoKardia and Bristol Myers Squibb. Her experience includes managing Contract Development and Manufacturing Organizations (CDMOs) and overseeing phase-appropriate process development from pre-clinical stages to commercial launch.