Experience

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  EUROAPI

  • Haverhill, England, United Kingdom

  • Technical Transfer Lead

    • Oct 2022 - Present
    • Haverhill, England, United Kingdom

    o Act as the key point of contact with the client for all technical matters through the Technology Transfer process. o Deliver, coordinate and manage the technology transfer of the products onto the site.o Lead and manage the internal site team against the defined project plans and deliverables.o Supporting the Business Manager in preparing quotes/statement of work required for a new client project either in the bidding stage or upon award of project.o Responsible for coordinating with the internal team for a robust GAP analysis to ensure that knowledge of product, process and operational aspects are transferred effectively between the Sending and the Receiving Units.o Responsible for clearly communicating the risks and mitigations to all the internal stakeholders and external partners/clients.o Responsible for detail planning, coordinating with other RU leads to consider individual transfers a part of overall facility schedule.o Maintaining point of contact with the client on technical issues and responsible for coordinating any internal responses with the relevant subject matter expert.o Accountable for client facing, technical communications for assigned tech transfers, technical discussions, presentations and written reporting to ensure the highest standards of technical competency and customer focus.o Responsible for raising the project change request where applicable and liaising with the Business Manager to ensure client agreement and payment.o Accountable for transfer close-out, ensuring robust lessons learned and reporting.

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  Sanofi

  • Haverhill, UK

  • Synthetic Chemist II

    • Jul 2006 - Oct 2022
    • Haverhill, UK

    Successfully completed APM Project Management Qualification.Team lead for writing and execution of validation documents to upgrade the manufacturing facility to GMP standard.Writing and reviewing validation documents URS/DRR/IQ/OQ for plant equipment's, utilities and cleanrooms. Development of a continuous hydrolysis process of polymeric drug product. Developed solid state NMR method for the analysis of polymeric drug product.Developed solvent free process for Metformin. Successfully synthesized and characterized impurities for API. Successfully characterized Amidites by NMR for synthesis of oligonucleotide. Part of technical team in successful implementation of continuous manufacturing of API on plant scale.Carrying out analysis & method development of the product using different techniques such as DSC, TGA, NIR, FTIR,GC, TGA-Mass, Particle Size using Mastersizer, particle imaging using Morphologi G3 & characterization using GC-MS, LC-MS and NMR.The work covers synthetic and analytical chemistry project growth from laboratory to GMP manufacture for phase 1, phase 2 and phase 3 clinical trial material. Writing Standard Operating Procedures and carrying out risk assessment.Preparation of documents related to the project and pilot scale development and presentation of research data.

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  Tonira Pharma Ltd.

  • Anklwshwar, INDIA

  • R&D Officer

    • Jul 2001 - Oct 2005
    • Anklwshwar, INDIA

    Develop and execute the synthesis of the desired organic compounds; Scale up the new processes to pilot plant; Optimize the existing chemical processes. Successfully developed the process for the synthesis of polymorphic mixture of Famotidine. Improved the process for insitu hydrolysis of Zolpidem cyano derivative to acid . Prepared Process development report, Validation protocol and Batch Manufacturing Records for FDA inspection.

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  Hind Dyes & Drugs Intermediates

  • Ankleshwar, INDIA

  • R&D Chemist

    • Jun 2000 - Jun 2001
    • Ankleshwar, INDIA

    Carrying out experiments in the lab under the supervision of the Department Head and to report the observations and the results of the same.Literature survey related to the project which includes searching the data related to the project on internet (patents, organic synthesis), journals and library-based searchTo maintain stock and ordering of the required stock of chemicals and glassware items.