Mayumi Bowen, MEng

Bio:

Mayumi Naito Bowen is a distinguished Senior Principal Engineer and accomplished Drug-Device Combination Product Development Leader with over 30 years of transformational experience in the biopharmaceutical and pharmaceutical industries. Currently at Genentech, she works in dual leadership roles as a Device Development Team Lead for multiple CMC combination product programs and Technical In-Licensing Project Lead.

Mayumi's technical mastery encompasses cGMP compliance, advanced drug formulations, device design control, neuro-ophthalmic drug delivery systems, human factors engineering, sterilization validation, aseptic filling, lyophilization, and regulatory excellence.

A proven leader, Mayumi excels at managing cross-functional teams and directing complex projects from conception through commercialization. Her career includes significant contributions to multiple drug-device combination products that have achieved regulatory approval and commercialization. Her in-licensing leadership includes conducting comprehensive technical due diligence assessments, evaluating asset manufacturability, development maturity, and cost implications. Her contributions are documented through multiple peer-reviewed publications and several U.S. and international patents covering innovative drug delivery systems and combination product innovations.

Born and educated in Japan, Mayumi earned her B.Eng. and M.Eng. in Materials Science and Engineering from Tokyo University of Science. With her deep technical experience, regulatory knowledge, and unwavering commitment to advancing patient outcomes through breakthrough combination products, she remains a visionary driving innovation across chronic, ophthalmologic, and neurological therapeutic areas.