Hidetoshi Yamamoto
About Hidetoshi Yamamoto
Hidetoshi Yamamoto is a Senior Manager in Quality Assurance at Kite Pharma, specializing in CAR T therapies. With extensive experience in pharmaceutical sciences and quality assurance, he has held significant roles at various companies, including Shionogi & Co., Ltd and Bristol Myers Squibb.
Work at Kite Pharma
Hidetoshi Yamamoto currently serves as Senior Manager of Quality Assurance for Kite Pharma, a Gilead company, since 2022. His role focuses on carT site qualification, where he oversees quality assurance processes to ensure compliance with regulatory standards. His responsibilities include managing compliance audits for various aspects of pharmaceutical production, including API, aseptic formulation, and distribution. He has been instrumental in maintaining high standards of quality assurance within the organization.
Education and Expertise
Hidetoshi Yamamoto holds a Master's degree in Pharmaceutical Sciences from 大阪薬科大学-大学院, where he studied from 1988 to 1994. Additionally, he was a Visiting Scientist at the University of Basel from 2006 to 2007. His educational background has equipped him with a strong foundation in pharmaceutical sciences, which he has applied throughout his career in various quality assurance roles across multiple companies.
Background
Hidetoshi Yamamoto has extensive experience in the pharmaceutical industry, having worked for prominent companies such as Shionogi & Co., Ltd, Bristol Myers Squibb, and Celgene. His career spans over two decades, beginning in 1994 as a Preformulation Scientist at Shionogi. He has held various positions, including Senior Quality Assurance Manager and Lead Auditor, showcasing his expertise in quality assurance and regulatory compliance across different pharmaceutical sectors.
Achievements
During his career, Hidetoshi Yamamoto has led significant initiatives, including the formulation development of cancer peptide vaccines for clinical trials. He has managed compliance audits across Japan, Asia, and the US/EU, ensuring adherence to international standards. His role as a lead auditor for joint audits of European and Indian API plants demonstrates his capability in conducting thorough evaluations without the need for translation, highlighting his proficiency in multicultural communication.
Professional Contributions
Hidetoshi Yamamoto was a member of the Forum for Innovative Regenerative Medicine (FIRM) until May 2021, where he contributed to the GCTP subcommittee. His involvement in this forum reflects his commitment to advancing the field of regenerative medicine and ensuring compliance with good clinical practice standards. Additionally, he has developed and implemented validation plans for aseptic processes, further showcasing his expertise in quality assurance.