Mohan Kumar Yernagula

Experience

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  Suven Life Sciences Ltd.

  Jun 2010 - Dec 2012

  Research Associate

  • Worked on major databases like USPTO, Escapcenet, WIPO and IPO• Involved in patent landscaping for generic as well as proprietary products for domestic and international markets• Implemented infringement analysis of products for various markets in the US and Europe• Prepared patent assessment reports, clearance reports, risk assessment notes, which includes building stands for relevant patents and prepared drafts for office action

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  Dr. Reddy's Laboratories

  Dec 2012 - Jun 2018

  Formulation Scientist

  • Identified opportunities for process improvements in current unit operations• Prepared pre- and post-stage technical risk assessment (TRA) to mitigate the risk• Planned and executed process optimization using DoE, scale-up and exbibit batches• Prepared and reviewed safety health & environment (SHE) documents, process optimization/scale-up report, master production records (MPR), process validation protocol/report (PVP/PVR), hold time study protocol (HSP), stability protocols and intended process validation protocol and BMR preparation• Investigated OOT’s, OOS’s, Incidents and Deviations and identified the root causes using investigational tools and proposed corrective and preventive action plan• Implemented QbD elements and FMEA for manufacturing lab, scale-up and exhibit batches• Prepared and submitted supporting documents to the regulatory affairs department• Coordinated with cross-functional departments involving purchase, analytical, production, regulatory affairs, quality assurance, quality control and API manufacturing personal Show less

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  AUROBINDO PHARMA LTD

  Jul 2018 - now

  Assistant Manager

  • Designing batch size as per the available equipment's• Executing process optimization, scale-up and exhibiting batches for solid oral solid dosage form at the production level• Engage in technology transfer of products from different sites.• Reviewing protocols, plans, batch records and documents generated during process optimization and exhibit batches• Effectively reviewing the bill of materials (BOM) to procure materials for process optimization and exhibit batches• Investigating process non-conformances (PNC) and out of specifications (OOS)• Currently working on process optimization and scale-up of Multiple particulate system (MuPS) dosage form comprising a proton pump inhibitor which is drug layered on sugar pellets and compressed into a gastro-resistant tablet.• Successful in process development and exhibit batch manufacturing of a platelet aggregation inhibitor in MuPS for European market Show less