James Gucwa

Senior Scientist, Assay Technology Innovation and Development, Abbott Rapid Diagnostics

Carlsbad, California, United States

About

Talented scientist with experience in molecular diagnostic's and synthetic biology, specifically in assay development for infectious disease and Isothermal DNA amplification in microfluidic devices. Skilled in Isothermal DNA amplification, qRT-PCR, Multiplex PCR, IVD Assay development, QC method development, Technical document writing for FDA 510(k) clearance. Strong research background with a Master of Science (MS) focused in Molecular Biology from University of California, San Diego.

Experience

  • Senior Scientist, Assay Technology Innovation & Development at Abbott
    Jul 2021 - Present · 5 yrs

  • R&D Scientist at Iridia, Inc.
    Jan 2019 - Jun 2021 · 2 yrs 6 mos

    Demonstrating POC of DNA-based data storage devices

  • GenMark Diagnostics (Carlsbad, CA)
    • Sr. Research Associate at GenMark Diagnostics, Inc.
      Jul 2014 - Jan 2019 · 4 yrs 7 mos

      Adapted Isothermal DNA Amplification techniques to a digital microfluifdic platform for electrochemical detection of Respiratory Pathogens Developed and optimized Multiplex-PCR assays for Fungal pathogen (BCID) Blood culture Identification product. Wrote and executed multiple analytical studies that in part lead to FDA 510(k) clearance of the BCID-Fungal Pathogen Assay

    • Research Associate II
      Jul 2014 - Feb 2018 · 3 yrs 8 mos

      Assay Development- Developed and optimized multiplex RT-PCR assays for Central Nervous System CNS) infectious disease targets on a sample to answer molecular diagnostic platform. Evaluated sensitivity and optimized sample preparation of assay targets in Cerebral Spinal Fluid (CSF) Assay Transfer- Designed and developed QC Methods for enzyme activity, qPCR contamination monitoring, and final product QC. Organized and ran precision studies to set QC method acceptance criteria and specifications. Wrote QC Method documents and forms. Performed stability and freeze/thaw studies on bulk enzyme formulations.

  • Staff Research Associate at University of California, San Diego
    Jun 2011 - Jul 2014 · 3 yrs 2 mos