sanjaykumar patel

Group Leader at Sigmapharm Laboratories
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Location
Bucks County, Pennsylvania, United States, US

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Experience

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Group Leader
      • Apr 2018 - Present

      Leading and managing group of 7scientists for all analytical method developmentand Validation for Raw materials and Finishproducts of Tablet/Capsules using sophisticated analytical instruments suchas HPLC, UPLC, GC, ICP-MS,Particle size analyzer, UV-VIS Spectrophotometer and FTIR.Provide guidance for developing analyticalmethods for Assay, impurity ,Residualsolvents and Dissolution,particle size studies for Finishproducts and Raw materials.Method validation protocol preparation,review test results for soundness, accuracyaccording to cGLP and cGMP.Supervises, guides and trains members ofthe analytical group to develop and optimizenew and existing analytical methods to meetdeadlines lied to product developmentschedules and to fulfill technical andcompliance requirement.A plan, schedules, coordinates and assignswork and establishes goals and priorities forsubordinate employees.Train, Supervise and evaluate the memberof the any kind of analytical development andvalidation team.Resolves problems encountered duringdaily operations and determine standards forproblem resolution and reviews work uponcompletion for adherence to ICH, currentguidelines and standards.Skill in prioritizing and scheduling work toallow for efficient and effective completion ofwork.

    • Senior Scientist 1
      • Jan 2017 - Present

    • Scientist ( AR & D)
      • Dec 2013 - Jan 2017

    • United States
    • Personal Care Product Manufacturing
    • Analytical Chemist ( AR&D )
      • May 2012 - Dec 2013

      Developed and validated methods for the analysis of assay, related substances and dissolution.Experience of writing method validation protocols, reports and writing the standard test procedures as per validation reports.Performed tasks as assigned for development, validation and tasks related to responding FDA deficiencies.Performed in-process, release and stability testing of product for Blend-Assay, Uniformity, Content Uniformity, Assay, Related Compounds.Performed release testing of raw materials. Proficient in operation of HPLC, GC, UV/Vis, FTIR, Atomic Absorption Spectrometer (AAS), Dissolution (Apparatus I & II), Karl Fischer for release and stability of products.Experience on Dissolution test and further study by using UV-VIS or HPLC.Expertise in using and analyzing data using Empower-II software.Handling of OOT and OOS.Peer review of laboratory notebooks.Experience of working under current Good Manufacturing Practice (cGMP) environment.Good analytical and communication skills and can work under pressure, quick learner and team player.Experience of creating, updating, revising of Standard Operating Procedures, Test Procedures by coordinating with supervisors.Assisting Supervisor in Laboratory Investigations.Handling, Maintenance & troubleshooting of HPLC (Shimadzu, Agilent, Waters), UV (Shimadzu), TOC (Shimadzu L- Series TOC analyzer), Atomic absorption Spectrophotometer (Perkin Elmer) , FTIR (Perkin Elmer), Gas Chromatography (Hewlett Packard)

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QC Chemist
      • Jan 2011 - May 2012

      Performed release and stability testing of products for Assay, Uniformity.Performed release testing of raw materials by wet chemistry techniques. Handling analytical instruments like High Performance Liquid Chromatography (HPLC), GC, TLC, Dissolution and UV – Visible Spectrophotometer etc.Preparation of common Buffers, Solutions and Laboratory reagents.Performed Calibration and Validation of various laboratory instruments.Carrying out the stability studies. Performed release and stability testing of products for Assay, Uniformity.Performed release testing of raw materials by wet chemistry techniques. Handling analytical instruments like High Performance Liquid Chromatography (HPLC), GC, TLC, Dissolution and UV – Visible Spectrophotometer etc.Preparation of common Buffers, Solutions and Laboratory reagents.Performed Calibration and Validation of various laboratory instruments.Carrying out the stability studies.

    • QC Chemist
      • Jan 2006 - Aug 2007

      Proficient in the use of analytical technique and instrumentation including HPLC, GC, TLC, UV-VIS spectrophotometer, pH meter, Balances, Karl fisher, Dissolution etc.Bulk density, Tap density and Particle size by sonic sifter.Co-worked with HPLC senior analyst, Responsibility includes like Preparation of Mobile phase,Standard and sample as per monograph method and In-house method.Swab sampling for cleaning validation at manufacturing site.Calibration of instrument like pH meter, Balances and Karl fisher.Review Temperature chart recorder for wet lab, instrument lab and stability chambers.Standardization Volumetric solution and test solution as per USP monograph.

Education

  • University of Bridgeport
    Master of Science, Technology Management; Biotech and Healthcare Management
    2008 - 2010
  • N.V.Patel Pure and Applied Science College
    Bachelor of Science, Chemistry
    2004 - 2007

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