Senior Drug Substance Development Consultant

Ravinder Sudini is an experienced synthetic organic chemist with over 19 years of experience in process research & development in API drug substance manufacture. Proven track record of originating synthetic ideas, developing and successful implementation of synthetic processes to API manufacture from pre-clinical to commercial supplies.

Ravinder has extensive experience in working with the most of API CROs and CMOs in Asia, Europe and US. He coordinates and leads manufacturing efforts by directly involving himself in all aspects of development and manufacture. This includes the research and development of new synthetic routes for small molecules API, intermediates, and impurity control.

His experience covers the identification and development of synthetic routes for rapid scale-up for laboratory-based manufacture of API for clinical supplies, and development of cost-effective final manufacturing processes, and through validation of processes in commercial manufacturing equipment.

He contributed to manufacturing processes with Quality by Design (Quds) principles, technology transfer and commercial launch activities of the Orient and Tapinarof. Ravinder has extensive knowledge of phase appropriate analytical methods and specifications to support projects development along with the regulatory dossiers’ submissions (INDs, NDA, MAA & ROW).

Ravinder received his PhD in Synthetic Organic Chemistry from National Chemical Laboratory, India before moving to Japan to carry out Post-doctoral assignment with Prof. M. Hirama at Tohoku University, and with Prof. T. Fukuyama at University of Tokyo. Later he moved to the US and has completed another post-doctoral assignment with Prof. Y. Kishi at Harvard University prior to starting his pharmaceutical career with GlaxoSmithKline, where he held multiple roles on projects scientific and leadership.

Ravinder has received a number of awards including GSK’s two Exceptional Science Awards and has published papers in external and internal GSK Chemicus and has 3 patents to his credit.

Examples of projects completed:

  • Invented commercial manufacturing process route to Tapinarof API synthesis (approximately 90% cost reduction vs initial route A).
  • Lead and executed conditions which resulted in approximately 90% cost reduction (vs previous route A5) to final pazopanib hydrochloride (Votrient) manufacturing route.
  • Experience in Quality by Design (QbD) as applies to drug substance synthesis of Votrient and Tapinarof,
  • Supervision of 200+ pilot plant runs at CROs/CMOs, GSK’s R&D and commercial sites for the API deliveries.
  • Manufacturing and Supply sourcing strategies, and contract manufacturing partner selection for raw materials, impurities, starting materials, advanced intermediates & API.
  • Experienced at managing the internal and external projects (CROs/CMOs) and leading multidisciplinary teams.