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Dr. Kedar Sinari is a seasoned pharmaceutical professional with a strong background in technical operations, product development, and quality management. He has led multiple projects and companies, including VASUDHA CHEMICAL PVT LTD, SATELLITE PHARMACEUTICALS PRIVATE LIMITED, and Thinq Pharma-CRO, Mumbai. Dr. Sinari holds a Ph.D. in Medicinal and Pharmaceutical Chemistry from the University of Chemical Technology, Mumbai.

Experience

  • VASUDHA CHEMICAL PVT LTD
    • Taloja,Mumbai,Maharashtra
    • Technical Director
      • Aug 2018 - Present
      • Taloja,Mumbai,Maharashtra

      • Leading, guiding, executing the entire technical operations of company (product development, production, QC, QA)• Main role in obtaining FDA-GMP certification (for pharma), FSSAI (for food) and FSSC certification (for food)• Developed new products with stringent specifications into food industry products and brought entire company operations under QMS leading to FSSC certification• Manufactured food as well pharmaceutical products in the same facility ensuring proper segregation of operations and ensuring compliance• Developed and outsourced manufacturing of new food products • Added quality control infrastructure like HPLC, GC, head space GC and many others for analysis to ensure relevant testing in house and compliance.• Developed QMS system with relevant documentation and its effective implementation to meet all regulatory requirements of pharmaceutical customers.• FDA approved Key Resource for organization for Production and Quality control • FSSAI approved Food Business officer

  • SATELLITE PHARMACEUTICALS PRIVATE LIMITED
    • Aurangabad, Maharashtra, India
    • Director of Operations
      • Jun 2013 - Jul 2018
      • Aurangabad, Maharashtra, India

      • Lead company to execute multiple projects successfully• Headed entire chain of operations of plant right from project selection, R&D, marketing, sourcing, production, quality control, documentation and handling government agencies. • In 5 years, the turnover escalated from 1.5 Crs. to 6 Crs. after development and commercialization of technology for one intermediate which made Satellite Pharma largest manufacturer of that particular intermediate in India.

  • • Thinq Pharma-CRO, Mumbai
    • Mumbai, Maharashtra, India
    • Senior Group Leader
      • Oct 2008 - May 2013
      • Mumbai, Maharashtra, India

      • Lead the entire R&D division of 12-15 chemists, successfully executed multiple projects for foreign clients involving initial route screening; development of robust process for scale up and custom synthesis.

    • Senior Research Scientist, Discovery services
      • Sep 2006 - Sep 2008
      • Singapore

      • Medicinal chemistry support services: Responsible for the design, synthesis, purification and shipping of NCE on FTE basis for clients on small scale.• Analyze and interpret chemical entities using HPLC, GC, LC-MS, GC-MS and NMR.• Process research: Successful completion of one-year project involving process research, development and optimization on FTE basis.

  • Pfizer Pharmaceutical India Pvt. Ltd.
    • Mumbai, Maharashtra, India; Pfizer - UK
    • Senior Research Scientist, Process Chemistry
      • Mar 2006 - Sep 2006
      • Mumbai, Maharashtra, India; Pfizer - UK

      API intermediates , scale up

  • • Domestic & Overseas, Mumbai
    • Mumbai, Maharashtra, India
    • Group Leader, Contract Research
      • Jun 2004 - Mar 2006
      • Mumbai, Maharashtra, India

  • • Ciba (India) Pvt Ltd, Mumbai
    • Mumbai, Maharashtra, India
    • Research And Development Associate
      • Apr 2003 - May 2004
      • Mumbai, Maharashtra, India

Education

  • 2000 - 2003
    • University of Chemical Technology, (UDCT)Mumbai
    Ph.D. (Tech), Medicinal and Pharmaceutical Chemistry
  • 1997 - 1999
    Principal K. M. Kundnani College of Pharmacy
    Master of Pharmacy, Research and Development Management
  • 1993 - 1997
    • Bharati Vidyapeeth College of Pharmacy, Mumbai
    Bachelor of Pharmacy - BPharm, Pharmacy

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