My role at Thermo Fisher Scientific is to develop and launch qPCR assays. Responsibilities include: -Writing protocols and reports for the development of regulated projects-Overseeing the execution of studies internally or by external CRO's-Executing laboratory procedures as necessary-Acting as a liasion to align functions such as manufacturing, R&D, quality, and regulatory-Implementing regulatory strategies for EUA, 510(k), CE-IVD, and IVDR products

My role at DCN was to design and develop lateral flow immunoassays for a wide range of applications. I have developed assays in various formats and with many sample matrices such as urine, blood, plasma/serum, saliva, insects, stool, and nasal/nasopharyngeal swabs among others. I have extensive experience with conjugation techniques to various particle types (both passive and covalent conjugations to gold, latex, cellulose nano beads, nano shells) and optimization to ensure the best performance. I developed diagnostic assays beginning with initial antibody and reagent screening, evaluation of all assay components and materials, and development of effective buffers and delivery systems to achieve the desired assay specifications. I have successfully developed assays from early feasibility to verification and manufacturing at a large scale under an ISO13485 system.I was also responsible for data interpretation and providing results and updates to clients in real-time. With consistent and effective communication to clients, I was able to execute successful assay development programs.

-Designed and developed lateral flow assays using novel nanoparticles-Managed the lateral flow development team on a wide range of lateral flow assays-Managed project budgets, resources, and timelines-Responsible for hiring research associates and implemented training protocols-Successful writing of grants & proposals for project funding & client acquisition-Direct supervisor of manufacturing transfer of assay for a non-profit organization-Development of ISO 13485 quality system documents for first production lot of assays-Technical representative for AACC 2016, AACC 2017, MEDICA 2017-Development of protocols, marketing tools, and customer support as well as hosting a lateral flow webinar and writing a handbook. Technical protocol published in Millipore-Sigma handbook, ‘Nanomaterial Bioconjugation Techniques’ 2017

-Development and optimization of qualitative and quantitative lateral flow assays-Colloidal gold preparation, gold conjugations, sample preparation and testing -Data collection and analysis -Responsible for independent projects