Experience

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  Glenmark pharmaceuticals

  Jun 2009 - Jan 2010

  Project trainee

  Well known about routine analysis of various drug substances and analytical assay method development of drug substances apart from conductance of project work as a part of academic curriculum.

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  Lupin pharmaceuticals

  Aug 2010 - Aug 2012

  Research associate

  Worked on Inhalation Drug Product Analytical Development viz. DPI and MDI.I was involved in routine analytical testing and characterisation testing using Copley instruments such as NGI, ACI, DUSA, TSI and MSLI. Well known about qualification of Copley instruments like vacuum pump, flow meter, critical flow controller and other related instruments like DUSA apparatus, twin stage impinger.Proficient in operation, maintenance and calibration of analytical instruments like HPLC (Schimadzu and Dionex ultimate with Chromeleon software), IR (Perkin Elmer), UV (Schimadzu 1600), Metrohm Potentiometer and KF titrator, pH meter, Precision balance and IR moisture balance. Show less

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  Novartis

  Sept 2012 - May 2015

  Associate scientist

  I have been associated with analytics solid oral drug products which specifically includes stability testing of early and late phase clinical batches of oncological products, preformulation studies, characterization studies, method development and optimization, validation and method transfer with fully GMP compliant lab. Has good exposure of facing health authority audits such as USFDA, Health Canada, Polish authority and internal global compliance audit, HSE audits of Novartis.

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  Sun pharma

  Jun 2015 - Mar 2019

  Senior executive

  Analytical research and development of drug products viz.Dry powder and Metered dose inhalers, Nebulisers, Injectables, Nasal preparations, Ophthalmic preparations for generic drug product approvals to US, EU, Health canada and ROW markets.Expertise in handling sophisticated instruments such as Sciex Qtrap LC-MS, ICP-MS for elemental impurities, Waters HPLC with PDA, UV, ELSD, RI detector, Schimadzu GC, Proveris Sprayview, Malvern instruments such as Mastersizer, Spraytech, Innovasystems instruments such as ADSA, MDI-ACS, MDI-DW, Injectable testing instruments such as Liquid Particle Counter, Anton Parr Viscometer, Nikon inverted microscope, tensiometer, osmometer etc. Show less

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  Glenmark pharmaceuticals

  Apr 2019 - now

  Senior research officer

  Analytics of Drug Product Development of Complex Injections and Nebulizer Inhalations.Follows QbD/DoE approach as per ICH Q8-Q10 guidelines for quality systems for drug product development. Follows recent ICH Q14 guidelines for method development viz identity ATR, MODR, working space and control space and risk assessment.Risk assessment using tools like FMEA, Fishbone. Validation of test methods and life cycle management of those test procedures.Performed Reverse Engineering of pharmaceutical formulations wrt innovator.Actively involved in the design and execution of In-vitro sameness charecterization using Population bioequivalence and Average bioequivalence for drug products.Involved in transfer of methodology to manufacturing site. Evaluated API and excipients from vendors. Performed equivalency study with compendial methods and in-house test methods. Performed extraneous peak evaluation for assay and RS test methods.Actively planned and executed DMF deficiency work after query response. GAP analysis as per recommandetion for drug products. Show less