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Nikhil Kulkarni

Nikhil Kulkarni

Teaching / Research Assistant

Followers of Nikhil Kulkarni778 followers
location of Nikhil KulkarniSingapore

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  • Timeline

  • Skills

    Gmp
    Gdp
    Commissioning
    Quality assurance
    Protein purification
    Pcr
    Biotechnology
    Sds page
    Protein chemistry
    Fplc
    Molecular biology
    Matlab
    Bioinformatics
    Monoclonal antibodies
    Research
    Elisa
    Microbiology
    Gel electrophoresis
    Drug delivery
    Bloodborne pathogens
    C
    Microsoft office
    Python
    Microsoft excel
    Powerpoint
    Data analysis
    Html
    Autocad
    Real time pcr
    Windows
    Validation

  • About me

    Sr. CSV Specialist | Industrial Automation | Process & Quality Consulting | CSV Specialist | GxP Validation

  • Education

    • KIT's College of Engineering, Kolhapur

      2007 - 2011
      Bachelor of Engineering (B.E.) Biotechnology

    • Birla Institute of Technology and Science, Pilani

      2011 - 2013
      Master of Engineering (M.Eng.) Biotechnology

  • Experience

    • Birla Institute of Technology and Science, Pilani - Goa Campus

      Aug 2011 - Dec 2012
      Teaching / Research Assistant

      - Taught Basics of Biology to First Year Engineering students. Arranged Lab Sessions and carried out practicals for First as well as Second Year Engineering students at BITS Goa.- Worked as a part-time Inventory assistant at the Scientific Departmental Stores at Department of Biology, BITS Pilani Goa Campus.

    • Hetero Drugs Ltd

      Jan 2013 - Jul 2013
      Trainee

      Worked as a trainee in the R&D Department (DSP). Leaned the handling of various processes involved in Downstream Processing of Monoclonal Antibodies and the handling of instruments such as -ÄKTA Prime Plus, ÄKTA Explorer 100 and ÄKTA Avant 150, ÄKTA Purifier, ÄKTA Process.

    • Malaria Evolution in South Asia Research Center

      Oct 2013 - Aug 2014
      Research Associate

      One of the few Research Centers in India, concentrating on Malaria Research, funded by National Institute of Health, USA through University of Washington. Ongoing activities include: inclusion of Malaria Positive patients, collection of blood, sampling, storage, PCR as well as Culture studies etc.

    • Biocon

      Sept 2014 - Mar 2015
      Intern

      Working as an intern at QA Validation at Biocon, Bangalore.

    • Biocon Biologics

      Jul 2015 - Apr 2021
      Senior Executive Engineer

    • Cognizant Life Sciences Manufacturing

      Apr 2021 - Mar 2022
      Quality Assurance Engineer

    • Infosys

      Mar 2022 - Dec 2022
      Consultant

    • PSC Biotech Corporation

      Nov 2022 - Nov 2023
      Senior CQV Specialist

      ✓ Senior CQV Specialist at Lonza.✓ Plan and coordinate computer software validation projects and activities.✓ Provide regulatory compliance, guidance and support on CSV activities✓ Create, review and approve system validation deliverables using industry standard electronic paperless validation tools.✓ Perform End-to-End Computer System Validation activities in accordance with GAMP 5, 21 CFR Part 11, Eudralex.✓ Validating Delta V DCS system for industrial manufacturing.

    • Process Engineering Specialists

      Nov 2023 - now
      Senior CSV Engineer

  • Licenses & Certifications

    • Kneat Academy Power User

      Kneat Solutions

  • Volunteer Experience

    • Volunteer

      Issued by NIRMAAN Organization
      NIRMAAN OrganizationAssociated with Nikhil Kulkarni