PROFILE SUMMARY
Biopharmaceutical Industry Veteran with 28 years of experience and a strong background in biologics and biosimilars development and manufacturing. Proficient in managing technical, regulatory, and business functions, with expertise in biopharmaceutical CMC development, GMP,operations and managing collaborations.
EXPERIENCE HIGHLIGHTS
Freelance
Independently engaged with the biopharmaceutical field in diverse activities of common interest.
Freelance consultant supporting small and large organizations in CMC development, manufacturing facilities establishment, business plans, CMO-client relationships and mentoring for organizational growth.
Involved with academic institutions to support teaching and research activities.
Syngene International Limited
Headed Syngene's biologics CDMO service vertical with end to end responsibility for the business and technical functions. The services included early and late phase development and clinical and commercial supplies of biologics to clients globally.
Responsible for India's first commercial contract manufacturing of a novel biologic for the US market.
Supported Syngene biologics CDMO activities in advancing specific business plans, technical projects and client collaborations.
Vice President - Pharmaceutical & Biologics Development
Established and led the India's first and leading integrated biologics CDMO business providing contract services for development and manufacturing of novel biologics and biosimilars, from pre-IND through commercial supplies for global markets. Helped advance the biologics pipelines of multiple clients, from big pharma to startups, in diverse geographies. Responsible for India's first commercial contract manufacturing of a novel biologic for the US market.
Headed a large group providing analytical and stability testing services to a global pharmaceutical company to support developmental and commercial products.
Intas Biopharmaceuticals
Chief Operating Officer
Established and led the Biotechnology company of the Intas group. Direct responsibility for R&D, commercial manufacturing, regulatory affairs and international business development. Significant achievements include commercializing 4 biosimilar products, the first biosimilar Pegfilgrastim in the world, India's first EU-GMP certified biologics manufacturing plant and the development of 2 products for filing as biosimilars in EU - both were approved and are marketed in Europe, including Grastofil - India's first biosimilar approved in Europe.
Wockhardt Research Centre
Senior Scientist - Biotechnology Division
Group leader for process development and manufacturing of biopharmaceutical products in mammalian and yeast expression platforms. Led teams working on Erythropoietin (India's first recombinant therapeutic), recombinant Hep-B surface antigen vaccine and recombinant Insulin, .