Experience

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  Mylan

  Oct 2015 - Mar 2016

  Project trainee

  Development of stable liquid parenteral formulation of COX-II inhibitorGot hands-on work experience on NETZSCH’s Delta Vita media mill, Kinematica’s Polytron homogenizer, Niro-Soavi’s Homogenizer Panda NS1001L 2K, Malvern’s Mastersizer, Malvern’s Zetasizer.Involved in design and process optimization of ophthalmic emulsion of a corticosteroidal drug.Development and process optimization of Extended release injectable suspension of an anti-psychotic drug.

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  Mylan

  May 2016 - Apr 2018

  Working as an officer-trainee in Injectable Department, as a Formulation Research Scientist. My role encompasses:Product Development and process optimization of ongoing projects which includes;1. Development of microsphere containing anti-psychotic drug as an extended release intramuscular injection.2. Design and process optimization of microsphere containing an Opiate Antagonist drug as a powder for injection.Being adept at relevant documentation like PDR.Following procedures towards Licence application of the product or API/excipients that are used in the formulation. Maintaining inter-departmental compliance with QA/RA/IPR.Following GLP practices. Show less Development and process optimization of Extended-release injectable suspension of an anti-psychotic drug.Design and process optimization of ophthalmic suspension of a Non-steroidal anti-inflammatory drug.Handling of topical corticosteroidal anti-inflammatory injectable suspension.Gained sufficient instrumentation expertise that involved:Hands-on experience on NETZSCH`s Delta Vita media mill (nano mill), Kinematica`s polytron homogenizer, Niro-soavi`s homogenizer Panda NS1001L 2K, Malvern`s Mastersizer and zetasizer, LSI & Vertis lyophilizer. Show less

  • Officer-trainee

    May 2017 - Apr 2018

  • Trainee Scientist

    May 2016 - Apr 2017
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  Viatris

  May 2018 - now

  Senior research scientist

  working as a Senior Research Scientist in Mylan, my role encompasses:•Development and execution of Complex injectable formulations for US, EU and emerging markets•Process optimization and execution of Scale-up and Exhibit batches of the microsphere formulation at plant.•Addressing the problems and queries related to the development of prototype formulations, Scale up issues, supporting for technology transfer to production site.•Protocols development and performing various studies like Compatibility, Hold time, PSCS, Freeze thaw, In-Use stability, miscellaneous characterization and in vitro release studies of various formulations• Initiation, tracking and compilation of stability data for prototype formulation, development and pilot scale batches• Providing Agency’s deficiency responses with developed formulation and the designing gap studies• Preparing and presenting scientific literature, product development and summary reports, handling investigation of deviations and providing justifications.• Preparing various documents related to the product developments such as Specifications, MFR, BMP, tentative stability protocols• Preparing various documents related to the product developments such as Specifications, MFR, BMP, tentative stability protocols• Preparation of regulatory documents like PDR (Pharmaceutical Development Report) based on Quality by Design (QbD) approach and regulatory responses for various products.• Coordinating with various departments like production, analytical, purchase, regulatory, quality assurance etc. for smooth flow of the product development.• Constant follow ups with manufacturing site for availability of slots for scaling up the process and management of Inventories, Execution of submission batches considering business requirements.• Equipments handled: Handled Scalper and refiner (PSL), NETZSCH’s Delta Vita media mill, homogenizers, Malvern’s master sizers and zeta sizer, Anton par’s viscometer during the development Show less