Sharon Faust Email & Phone Number

Taunton, MA

E. Walpole, MA

Troubleshoot manufacturing issues relating to infectious disease immunoassays

Framingham

- 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)

Diagnostics R&D

• 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)..
• 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).

Diagnostics R&D

• 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.
• 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.
• 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.
• 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.

Diagnostics R&D

• 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.