Tania Rosen-Cheriyan

Tania Rosen-Cheriyan holds a PhD in Chemical & Biomolecular Engineering from Georgia Institute of Technology, and a bachelor’s degree in Pharmaceutical Sciences from the Institute of Chemical Technology in India. She is a skilled professional in bioprocess development and regulatory affairs and is currently serving as a CMC Reviewer at the Food & Drug Administration (FDA). At the FDA, she has contributed to the CMC review of multiple in-vivo gene therapy products at various stages of development, from early pre-clinical phases to post-marketing evaluations, with a focus on early stages of clinical development. Previously, as the Associate Director of Process Development at StrideBio, she led and mentored cross-functional teams to develop and transfer new AAV based therapeutics from lab to manufacturing. Tania's expertise also includes the downstream process development of monoclonal antibodies and Fc fusion proteins, and leading interactions with various clients at a CDMO, KBI Biopharma. She has authored numerous technical documents and research plans, driven by a commitment to quality and innovation in the biopharmaceutical field.