Karthik Dhanaraj, Ph.D.,

Experience

• 

  Merck Life Science

  Aug 2005 - May 2014

  • Responsible for downstream process (protein and antibody purification)• Expertise in protein identification and characterization; 2D electrophoresis, peptide mass fingerprinting (PMF) and MALDI-TOF-MS• Performed assay for protein and antibody• Expertise in antibody development and conjugation with HRP/ALP/FITC/Biotin/drug molecules• Expertise in human recombinant protein purification [EMD Millipore Project (USA)]• Expertise in coupling of ligands with agarose; proteins, antibodies and small molecules such as IDA, TED, Heparin, Glutathione and Cibacorn blue• Responsible for manufacturing of bioscience kit (research and teaching kit)• Responsible for costumed service for protein purification/antibody development Show less

  • Associate Scientist (Downstream Process/Manufacturing)

    Apr 2012 - May 2014

  • Senior Scientific Officer - Immunology

    Apr 2010 - Mar 2012

  • Senior Executive - Immunology

    Apr 2008 - Mar 2010

  • Executive - Immunology

    Aug 2006 - Mar 2008

  • Executive Trainee

    Aug 2005 - Jul 2006
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  Trivitron Healthcare

  May 2014 - Dec 2015

  Assistant Manager – Research and Development (Diagnostics Division)

  Responsible for facility set up for protein/antibody purification and scale-up/facility set up for manufacturing area/development of rapid and ELISA kits/tech transfer of product from Finland / manufacturing of IVD products/quality/regulatory requirements. Completed set up of manufacturing facility and commissioned  Successfully completed of manufacturing license and GMP audit  Successfully product tech transferred from Finland to India facility [Rapid and ELISA (TORCH)] Assay developed for infectious disease (HIV 1 & 2, Hepatitis B, Hepatitis C, Toxoplasma and Rubella) Primary, secondary antibodies and antigens conjugate with HRP Successfully implemented of QMS ISO 13485 Show less

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  Abbott

  Dec 2015 - Jul 2018

  Manager - Quality

  Responsible as functional head of quality for the ARDx India Division and to manage all manufacturing products quality/regulatory requirements/Complaints for the products.

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  Transasia Bio-Medicals Ltd.

  Jul 2018 - Sept 2018

  Manager – Quality (Diagnostics Division)

  • Responsible to manage QC/QA/RA functions (Functional Head) team of 3 members and reports to Associate Vice President quality• Effective implementation of regulatory requirements as per medical device rule 2017 (test license/manufacturing license/import license/post approval changes/Adverse events)• Responsible to implement/maintaining of QMS (ISO 9001 and ISO 13485) with risk-based approach• Responsible to test/release all incoming/intermediates/FG as per business requirements and also complaint managements Show less

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  Cepheid

  Oct 2018 - now

  • Responsible to manage QMS, Regulatory, QC, QA, quality engineer, calibration functions.• Responsible to manage mfg. plant quality operations/commercial quality operations and its requirements.• Responsible as country quality lead/ regulatory compliance lead and management rep (MR)• Responsible to implement of regulatory and quality strategy/requirements• Core team member for commissioning of manufacturing facility (Established two manufacturing plant in India for Cepheid)• Core team member and responsible for product tech transfer from US and Sweden to India sites. Show less

  • Sr. Manager, Quality Systems and Regulatory Compliance

    Apr 2020 - now

  • India Quality Systems and Regulatory Compliance Manager

    Oct 2018 - Apr 2020