Led the R&D team that developed the first FDA EUA SARS-COV-2 rapid antigen test on the Sofia 1 and Sofia 2 platforms in May 2020. Subsequently developed the QuickVue At-Home OTC COVID-19 Test (EUA) and the SARS-COV-2 multi-analyte serology assay (CE). Critical decision-making, motivation and collaboration with all departments and external contacts were pivotal to meet the demands of the emerging pandemic. In 2023, the Sofia SARS Antigen+ assay became the first De Novo 510k and CLIA waived COVID-19 product. Direct managers, scientists and research associates to build and conduct early-stage discovery, research and analytical method development. Lead R&D discovery and technology assessment teams to find, design and characterize biomarkers, chemistry and platforms. This includes collaboration with external partners and key opinion leaders as well as internal business development leaders.

Managed and led a team of research scientists to develop CLIA-waived Sofia 2 Lyme (US) and Lyme+ (CE) Immunoassays that differentiate between the IgM and IgG response using whole blood finger stick, serum or plasma sample types with results in 15 minutes. Collaborated with Key Opinion Leaders and upstream marketing to design and evaluate product requirements. Worked with internal and external engineering groups to design a low volume whole blood separation device as well as the novel bi-directional LFA test cassette. Worked extensively with clinical and regulatory departments to design and execute clinical trials and 501k/CLIA studies and continue to support marketing with external post-launch studies.

Led the establishment of a startup point-of-care lateral flow R&D group, transforming office space into a functional laboratory by sourcing and purchasing equipment, materials, and samples. Built and supervised a core research team, handling recruitment, hiring, training, and ongoing mentoring. Implemented design control processes, document control, inventory management, and QC testing. Directed research associates and manufacturing personnel in developing four infectious disease lateral flow tests from conception to FDA approval, with strategic project planning and resource management. Maintained hands-on involvement in projects, spending 25-50% of time at the bench. Presented reports regularly to senior management, manufacturing, regulatory, sales, marketing, and external collaborators to ensure alignment and progress tracking.Led diverse projects including the qualitative detection of syphilis antibodies, giardia antigen, strep pneumoniae urinary antigen, and RPR antibodies across various sample types. Directed the syphilis project from feasibility to CE marking, with endorsement from the CDC and FDA submission. Managed verification, validation, and FDA approval for the giardia assay, ensuring ongoing manufacturing support. Collaborated with experts for strep pneumoniae assay feasibility and validation lot preparation. Worked with the CDC on lipid antigen modification for the RPR assay, demonstrating feasibility in a dual format.

As a primary scientist, led the development of various lateral-flow immunoassays including Influenza A/B, Cardiac (CK-MB, TnI), RSV, and stroke (MBP), overseeing multiple aspects of the product lifecycle. Responsibilities included planning and executing studies for feasibility, verification, and validation through FDA submission. Facilitated the transfer of Influenza A/B assay from Japan to the US, achieving FDA approval through internal studies. Developed and validated a quantitative assay platform for the cardiac program and redeveloped existing products like Giardia-Cryptosporidium, hCG, and Strep A. Collaborated with regulatory affairs on materials preparation, personnel training at clinical sites, and contributed to 510k and CLIA submissions, along with FDA responses. Worked closely with marketing leadership to design and execute studies meeting product specifications. Prepared documents and transferred technology to manufacturing. Provided regular updates to the product team and senior management through project reports and data presentations. Evaluated new products and technologies.

Developed a quantitative chemiluminescent LH immunoassay utilizing an analyzer-based platform. Acquired necessary reagents, samples, and materials for assay development. Biotinylated antibodies were prepared for conjugation to paramagnetic particles. Successfully adapted a preliminary tube assay into the quantitative analyzer format, demonstrating feasibility with clinical samples.

Led the research and development of Chlamydia, Strep A, and LH one-step lateral flow assays. Responsibilities included coordinating cross-functional efforts among sales/marketing, regulatory, manufacturing, and R&D teams for Chlamydia assays. Developed Chlamydia immunoassay and sample extraction methods, facilitated technology transfer to personnel in China, and created Chlamydia cell culture and immunofluorescent staining protocols.

Contributed to the research and development of the QuickVue Influenza A/B dipstick, various hCG midstream and semi-quantitative assays, the HSV I/II bi-directional assay, and a 16-analyte Allergy one-step lateral flow assay. Key functions included purifying, conjugating, and evaluating antibody/antigen pairs, as well as coupling them to mobile and fixed capture systems. Facilitated technology transfer from R&D to manufacturing, including training manufacturing personnel and drafting manufacturing documents and SOPs in GLP/GMP environments. Validated and implemented improvements to manufacturing procedures, notably in Influenza conjugation methods, and conducted trend analysis of in-process test results to ensure alignment with product specifications, QC regulations, and field performance standards.