Sanjeev Kothari

PROFESSIONAL SUMMARY: • Chemistry, Manufacturing and Controls (CMC) Team Leader with twenty-seven years of industry experience in various aspects of CMC as well as management of clinical and commercial supply chain operations. • Demonstrated ability to undertake broader roles and responsibilities in fast-paced, nimble biotech environments/companies that may require hands-on work as the organization is being built from ground up. • Executive level management skills relating to budget management, budget planning/forecasting, board presentations and creating new teams. • Skilled at negotiating vendor (CDMO/CRO) contracts, master service agreements and commercial supply agreements, as well as quality agreements. • Leadership experience in pharmaceutical development (early and late stage) at multiple large and small pharma/biotech organizations and developing products in multiple therapeutics areas that include oncology, neuroscience, metabolic disorders, gastrointestinal diseases, and kidney failure. • Preclinical stage experience: screening physical properties of multiple candidates, developability assessment of candidate molecules for solubility and identifying preclinical formulations for evaluation in animal models (rodents, dogs and monkeys). • Early-stage clinical experience: Participated in pre-IND meetings with the FDA, scaled up synthetic routes for APIs for Phase 1as well as developed several phase appropriate clinical stage formulations (oral, IV, IM and SC injectables). • Late-stage clinical experience: Carried projects through challenging clinical development timelines for world-wide registration and approval. • Regulatory Experience: CMC submissions (NDA, MAA, Canada-NDA etc.) and interactions with regulatory agencies which includes responses to questions and face to face meetings. Examples include: ABILIFY, ONGLYZA, KOMBIGLYZE-XR, COTELLIC, KYPROLIS, XPHOZAH and IBSRELA. • Demonstrated leadership of cross-functional CMC teams (chemistry, analytical and formulations) • Experienced with the first pilot program on Quality by Design (QbD) and QbD-internal expert for the Genentech/Roche QbD teams. Also, involved in evaluating continuous manufacturing concepts during early and late stage-development at AstraZeneca as well as Genentech/Roche. Quality Experience: Developed several SOPs at start-up or early clinical stage companies for processes related to product specifications, analytical procedures or method validations and risk assessment and risk management.