Ms. Yamamoto is a Project Director for TVS. She has over 28 years of experience in the biotechnology and diagnostic industries that includes validation and cGMP compliance in support of client commissioning, qualification and validation activities, project management, protein purification and technology transfer. She is a well-respected C&Q project manager and has led projects of up to $5M (in C&Q costs) with large teams of validation engineers. She is familiar with progressive, efficient and compliant validation project delivery methods, and her validation work has been successfully inspected by the FDA, as well as both CBER and the San Francisco District.
Ms. Yamamoto’s technical experience includes, but is not limited to, sanitary and non-sanitary utility systems, facilities, HVAC systems, manufacturing equipment such as bioreactors, process tanks, solution preparation modules, platform shakers, autoclaves, glass washers, membrane filtration skids, UF/DF skids, CIP skids, mixing stations, chromatography skids and columns, tangential flow filtration skid, centrifuges, bag mix bins, incubators, refrigerators and freezers, biosafety cabinets, isolators, capsule counter vision system and analytical instruments.
Ms. Yamamoto holds a B.A. degree from the University of California, Berkeley, and is an active member of the San Francisco Bay Area Chapter of ISPE.