Anjali Shukla

Anjali Shukla is a Supervisor in the Office of Pharmaceutical Quality, CDER, FDA, and a member of the Emerging Technology Team (ETT). She performs and supervises assessment of the chemistry, manufacturing and control (CMC) programs of biotechnology products at all stages of drug development and product lifecycle, as well as FDA pre-license inspections of biologic drug manufacturing facilities. Anjali serves as a CMC subject matter expert for insulin products. As part of the ETT, she engages with internal and external stakeholders in the development of novel manufacturing technologies. She has previously served as a product quality team lead and assessor for the CMC assessment of biotechnology products at FDA. Prior to joining the FDA, Anjali was a staff scientist at the National Cancer Institute, NIH, where her research elucidated novel mechanisms of skin carcinogenesis and breast cancer metastasis.