UNICAN: Dual capability in single use bioreactors Presented by Ekta Mahajan, Sr. Regulatory Program Director at Genentech Ekta Mahajan is a Sr. Regulatory Program Director at Genentech/Roche in South San Francisco, CA. Ekta has 19 years of industry experience, with 15 years in process development, three patent applications, and 10 external publications. In her regulatory role, she led the technical regulatory team for global filing of initial market application for a first Genentech fixed dose combination monoclonal antibody and leads a global clinical and CMC regulatory team to support product optimization. Prior to regulatory, she has fifteen years of experience in research and manufacturing experience in biotechnology, vaccines and pharmaceuticals, and lead projects in a wide range of areas, both upstream and downstream, including commercial manufacturing support, process development, and new technology evaluations. Ekta has expertise in disposable technology and is a recognized expert and thought leader in single-use technology both within Genentech and Roche and across industry groups. Before joining Genentech, Ekta was a process engineer at Merck, working on vaccines and process operations. Ekta was a process engineer at Merck, working on vaccines and process operations. She holds Chemical Engineering degrees from the Thapar Institute of Engineering and Technology, Punjab, India (Bachelor’s) and Bucknell University, Pennsylvania (Master’s).

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