Sreekanth Bachu

Background

About Sreekanth Bachu

Process Development for API Generics and New Molecules Entities • Developing cost effective, plant feasible and eco friendly process for Active Pharmaceutical Ingredients. • Cost reduction by continuous improvement in the process based on 6 Sigma, QbD and PAT approaches. • Technical guidance to the team's focus is on reducing costs and variability in process while maintaining API quality. • Provide project leadership and technical oversight scientists engaged in technical transfers and process development activities for Active Pharmaceutical Ingredients (API). • Synthesis, development pharma intermediates and specialty molecules in Custom synthesis and contract Research. • Literature survey and Infringement analysis followed by Lab Scale development, process improvement and consequent scale-up. • Experienced in developing robust processes through DOE • Supporting necessary documentation for DMF filings. • Designing & developing new routes/non infringing routes for the APIs. • Impurity profile study (Identification, synthesis and characterization of impurities of APIs). • Patent evaluation summary preparation and patent drafting.Having experience in supporting audits like USFDA