Developed and supported diagnostic tests for commercialization in US and EU Redesigned, implemented, and transferred manufacturing process for high-sensitivity antibody based nano-particles for use in the NephroClear Test.Supervised the execution and monitoring of assay standardization and metrological traceability of the NephroClear assay in accordance to ISO 17511.

Senior staff of small team that developed a new POC lateral flow platform and received FDA clearance for new test to assess risk of kidney injury.Provided technical support to operations group to ensure quality of products. Project lead to design and manufacturer “wet” calibration device for QC of the NephroCheck meter. Demonstrated feasibility of new NephroCheck assay with all monoclonal antibodies and subsequent transferred assay/antibodies to licensees (OCD and Biomerieux).

Launched FDA approved de novo 510(k) NephroCheck Test as senior member of Product Development team.Project lead to develop, transfer, and commercialize NephroCheck Liquid Controls and Cal Vers kit, including performing all related phases of Design Control activities necessary for submission to FDA. Designed and Implemented assay standardization plan for the NephroCheck Test.

Optimized and designed next-generation Troponin assay to achieve 5% CV at 20pg/mL conc. Technical lead for demonstrating feasibility of NGAL sandwich assay. Formulated gold-standard calibrators of 16 analyte drugs of abuse panel.

Helped launch high-sensitivity point-of-care test for Troponin I.Developed conjugation chemistry of magnetic beads used for new assay for BNP. Technical lead in transfer of canine BNP assay to Antech.