Sudhir Sawant

Senior General Manager R & d Apis @Fdc Limited

Mumbai, IN

Process development of generic API molecules using DoE & QbD techniques, technology transfer and validations for USDMF/CEP/ ROW regulatory filings. Managing team of scientists & responsible for market research, literature survey, feasibility studies, route selection, process development, cost optimization and transfer of commercially viable processes to internal and external manufacturing sites. Responsible for planning, budgeting R&D projects, Pilot Trials / Demo batches / Scale up batches in cGMP compliant manufacturing facility in coordination with Purchase, Production, Quality and EHS teams. Designing and writing SOP’s related to cGMP & Safety and training of PD Lab/Production personnel, technical reports & documentation. Supporting Regulatory Affairs for statutory approvals, licences, renewals from government regulatory agencies And Administration for fire safety and pollution control board approvals. Supporting Production/QA for closure of OOS/ Plant Deviations/ investigations, CAPA and Change control documentation for continuous improvement. Mentoring & coaching of team laboratory chemists to meet project goals. Motivate and retain key talent of the department. Training of production shop floor employees. Implemented 21CFR complaint electronic lab notebook software in Synthesis and Analytics.

Fergusson College

B Sc

Savitribai Phule Pune University

MSc Organic Chemistry

Alegaonkar High School Khadki Pune SSC1986

SSC

University of Mumbai

Doctor of Philosophy - PhD