Sumit Aggarwal

Experience

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  Shriram Institute For Industrial Research

  Jan 2000 - Jan 2002

  Analyst - A

  involved chemical analysis of samples of testing and analysis of various kind of samples (Raw materials and formulation) from Pharmaceutical industries using different instruments like HPLC, AAS, Spectrophotometer and FT-IR, etc; Worked on different types of ayurvedic products and raw material using instruments like AAS (Analytic Zena).

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  Dabur Research Foundation

  Sept 2002 - Jan 2004

  Reseach Scientist

  Method developmentMethod ValidationStability Testing

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  Regent Drugs Limited, TEVA

  Jan 2004 - Jan 2007

  Sr. Research Scientist

  Method Development and Method transfers of the various intermediates and end products for the purpose of Reaction Monitoring of various reactions and Qualitative and Quantitative tests for various end products using analytical Instruments like G.C., GC- HS and HPLC (UV, PDA & ELSD detectors). Preparation of SOP’s, STP’s and Specifications of the various intermediates and end products for the purpose of reaction monitoring of various reactions; worked in Validation group of Analytical development, Dabur Research Foundation, U.P. as “Research Scientist”.Validation, Method development and Stability testing of Generic drugs meant for regulated markets. Both by Official as well as In-house methods using instruments like HPLC, HPTLC, UV, and IR etc. Preparation of Validation report for Filling in different regions Show less

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  Teva Pharmaceuticals

  Jan 2004 - Feb 2007

  Research Scientist
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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Feb 2007 - Sept 2014

  Group leader responsible for Analytical Method development, Method validations and Stability monitoring programs for all phases of New Chemical Entities (DS and DP) development. Managing a team of 7-9 team members.Data review and Interpretation of the data generated by the analysts. Handling of GMP events and deviations viz. OOS, OOT, OOAc etc. and Change controls.Participation in fillings: Review of Dossiers (IMPD, NDA) & DMFs filing (Analytical modules). Writing Registration level protocol, Method validation reports and Stability reports for Registration Authorities. EMEA/ FDA Audit: Member of Core team who faced the Auditors as Subject Matter Expert.Preparation of SOP, Work Instruction and protocols for the operation, calibration and qualification of Instruments. Responsible for contribution and Implementation of Global standards.Initial Qualification of new Instruments: Preparation of Instruments Qualification Plan, User Requirements, Risk Analysis/ Risk Mitigation & Protocols (IQ, OQ and PQ).Project Management: APDC Project lead for various projects from US and Belgium sites for its end to end progress with strict time deliverablesProject Tracking and scheduling of activities via different tools.Coordination between different sites, different department and different vendors for smooth running of projects.Timely communication of project status via mails and presentations to partners across sites.Discussion on hurdles faced during various steps of formulation development and resolving issues on priority basis.Active participation in budgetary (OPEX and CAPEX) and FTE requirements.Additional Responsibilities:Member of Global and Site “Talent Development teams”.Member of Global CAPEX Committee.Responsible for Training calendar for the department.Implementation of Electronic note books (Symyx and Velquest) Show less

  • Group Leader- A R&D

    Feb 2007 - Sept 2014

  • Group leader

    Feb 2007 - Sept 2014
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  Syngene International Limited

  Oct 2014 - Aug 2020

  Laboratory Setup and startupInstrument procurement and InstallationProject Discussion and AllocationLab. Management Management of OPEX and CAPEX Laboratory Setup and startupRecruitmentInstrument procurement and InstallationProject Discussion and AllocationLab. Management Management of OPEX and CAPEX

  • Assistant General Manager, Syngene Bristol Myers Squibb Laboratory

    Apr 2018 - Aug 2020

  • Senior Manager, Syngene Britol-Mayers Squibb Laboratory

    Oct 2014 - Apr 2018