Experience

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  Pinnacle Life Science Pvt. Ltd (Subsidiary of Aarti Drugs)

  • Navi Mumbai, Maharashtra, India

  • Head of Formulation Research & Development

    • Sep 2022 - Present
    • Navi Mumbai, Maharashtra, India

    * Serving as HOD, directing & monitoring (HOD) Formulation Research Team inorganizing all aspects of Formulation R&D.* Overseeing, tracking, and complete executing (from resourcing to dossier filing) of all formulation development affairs for regulated markets, namely USFDA, EMA, UKMHRA, TGA, Health Canada and various national and international markets.* Proactively addressing critical pharmaceutical issues such as - pre-formulation, formulation & troubleshooting, analytical, bioequivalence and pharmacokinetic concerns and other relevant matters, in coordination with cross-functional departments.* Contributing with rational scheduled commitments for management milestones, assetsand requirements - prototype development, pilot Bioequivalence studies, scale-up studies, QBD-related studies, exhibit batches scheduling & filing etc.* Steering and observing - all aspects of systemic formulation development – API & RLD (RMP) sourcing & evaluation, Reverse Engineering, Pre-formulation studies, Formulation studies (Design of Experiments) on the QbD approach, Process Scale-up studies, Formulation and Process Optimization Batches and Manufacture of formulations for bioequivalence studies via exhibit batches.* Developing robust, patent, non-infringing and stabilized formulations following committed deadlines.* Engaging with multidisciplinary teams to render end-to-end project assistance from formulation development to exhibit batches, bio-studies & regulatory submission tasks.* Consistently observing the projects under development, evaluating & approving of Product Development Reports and regulatory submission documents.* Liaising with multiple departments, such as IPR, analytical research, purchase, regulatory, production, packaging development department, etc., to ascertain the effortless transition of the products under development.* Overseeing all aspects of product development and Product life cycle management.

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  Inventia Healthcare Limited

  • Thane, Maharashtra, India

  • General Manager, Formulation development

    • Aug 2017 - Aug 2022
    • Thane, Maharashtra, India

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  Lyrus Life Sciences

  • Bengaluru, Karnataka, India

  • General Manager, Formulation development

    • Mar 2015 - Aug 2017
    • Bengaluru, Karnataka, India

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  AUROBINDO RESEARCH CENTRE

  • Senior scientist Formulation development

    • 2006 - Mar 2015

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  Zydus cadila, ahmedabad

  • Manager, formulation development

    • 2001 - 2006

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  Dr. Reddy's laboratories, hyderabad

  • executive

    • 1996 - 2001