Troubleshoot manufacturing issues relating to infectious disease immunoassays

- Clinical assay development using ligand binding assays such as ELISA- Investigation of technical issues- Completion of routine scientific procedures and experiments- Analysis, interpretation and reporting of results- Contributing to the completion of routine laboratory tasks (equipment maintenance, supplies and general lab support)

• Tested over 10,000 patient samples using ELISA (spectrophotometric and electro-chemiluminescent) as part of a large clinical trial to identify a panel of biomarkers for early detection of acute kidney injury (AKI). Modified and validated commercial assays for the study. Publication with collaborators pending.• Executed internal audits against industry quality standards (ISO 13485, FDA Quality System Regulation and CMDR Canadian Medical Device Regulations) as a member of the diagnostic internal auditing team (DIAT).

• Adapted academic publication into a functional diagnostic Newborn Screening assay for the detection of lysosomal storage disorders. o Designed and implemented procedures for immediate spotting, drying, storing, and cataloging of whole blood samples for controls and stability studies.o Identified vendor for the design and production of a pipet aid enabling the transfer of a liquid organic phase in a 96 well plate format.o Developed assay for high throughput mass spectrometer screening applications and planned and executed validation, verification, and component stability studies.o Provided assay protocols, substrates, and internal standards to international and domestic screening labs.o Collaborated with the CDC to implement the method worldwide.• Developed an ELISA for Fibroblast Growth Factor 23 as a marker for chronic kidney injury. Screened antibody pairs and numerous assay conditions to enhance signal and eliminate non-specific background. Transferred assay to clinical group. • Generated data following CLSI guidelines resulting in a successful 510k application for a liquid reagent measuring serum Cystatin C, a biomarker for renal disorders. Responded to requests from the FDA for additional data. Successfully transferred assay to QC for market availability.• Provided training and oversaw summer interns’ efforts on clinical analyzers, ELISA assays, and protocols.• Created and maintained a logging system of swab samples for the Candida lateral flow assay, enabling easy and accurate access of matched sample sets for dual in-house and outside testing.• Identified outside vendors; purchased and utilized biological sample types, including serum/plasma, whole blood, stool, urine for the purpose of sample testing and generation of controls.

• Validated and supported liquid clinical chemistry assays measuring cardiac and liver biomarkers, including HDL, LDL, Lp(a), Amylase, and Lipase.o Planned, executed, documented, and reported validation studies for clinical chemistry reagents measuring HDL and LDL. These included precision, linearity, sensitivity, specificity, fasting vs. non-fasting studies, calibrator stability studies, etc. HDL product currently controls 70% of the US market.o Developed novel cyclic assay for the measurement of Homocysteine leading to the licensing and sale of product.