Minh Luu

Genentech, a Member of the Roche Group

Minh Luu is currently a Group Director in Pharma Technical Regulatory at Genentech, A Member of the Roche Group. She has more than 17 years of industry experience in biologics, working in areas of process development, manufacturing sciences, and CMC regulatory. Throughout her career, she has worked on programs from early stages of development to post-approval activities and supported a variety of cross-product topics such as LER & microbial control, Control System Lifecycle Management and QbD. She has also worked on many post-approval activities such as process version changes, process transfers, and control strategy updates for both recently approved and legacy products at Genentech. Her regulatory topics of interest include Established Conditions and RTRT. Minh holds a Bachelor’s in Chemical Engineering from the University of Waterloo and a Master’s in Chemical and Biological Engineering from the University of British Columbia.