Sangita Ghosh

About Sangita Ghosh

Drug development executive leading pharmaceutical product development, manufacturing, and global supply chain management. • Led the development of Tavneos®, Gocovri®, Namzaric®, Intermezzo®, Varespladib™ and pipeline products from concept to various stages of development and product approvals. • Led multifunctional teams in pharmaceutical development for solid oral dosage (controlled release and immediate release tablets, coated pellets, capsules), liquid oral dosage, parenteral and transdermal products. • Provide real time solutions to acute and chronic technical challenges in formulation and commercial process development. • Authored CMC sections of regulatory documents (IND, NDA, IMPD) and led phase appropriate CMC meetings with regulatory authorities. • Comprehensive knowledge and experience in Chemistry, Manufacturing and Controls (CMC), and Regulatory and compliance issues. • Experience in large pharma as well as in the emerging pharmaceutical company environment. • Developed and maintained relationships with external contractors for the development, manufacturing and packaging of clinical and commercial supply. SPECIALTIES CMC and Product Development: Controlled release drug delivery, Outsourced contract manufacturing, Commercial scale manufacturing and packaging, drug substance and drug product development, Formulation, Process development, transdermal, oral, solid, semi solid, liquid dosage, parenteral dosage Related Areas: Intellectual property, Technology transfer, Corporate strategy, General program management, Quality, Supply chain, Inter-company strategic alliances, IND, NDA, IMPD

Experience

1. Sr Vice President, Cmc

   Bioage Labs

   Jul 2024 — Present · US

Education

• Indian Institute of Science (IISc)

  Ph.D., Biophysics/Organic chemistry

  1993 — 1998

• Indian Institute of Technology, Kanpur

  M.Sc., Chemistry

  1991 — 1993