Provide strong technical leadership throughout all aspects of the company: Product development, system integration, analytical methods, process and assay specification setting, manufacturing transfer, process validation, design control, clinical trial design, verification testing, CE Mark Technical File creation, FDA submission and strategic planning.Key Achievements:• Achieved CE Mark for both Procise CRP assay and ProciseDx Analyzer• Completed US clinical trial for Procise CRP… Show more Provide strong technical leadership throughout all aspects of the company: Product development, system integration, analytical methods, process and assay specification setting, manufacturing transfer, process validation, design control, clinical trial design, verification testing, CE Mark Technical File creation, FDA submission and strategic planning.Key Achievements:• Achieved CE Mark for both Procise CRP assay and ProciseDx Analyzer• Completed US clinical trial for Procise CRP fingerstick whole blood, whole blood and serum• Completed 510(k) design verification testing• Completed process validations allowing for the commercialization of 4 assays to be CE Marked and launched early Q2 2020 Show less

Assisted with Several Product Launches within the CLIA Lab:o Monitor: serum test to assess the colon of Crohn’s disease patients without an endoscopyo Anser Ustekunimab (STELARA®): Therapeutic Drug and Anti-Drug Monitoring Testo Anser Vedolizumab (ENTYVIO®): Therapeutic Drug and Anti-Drug Monitoring Testo FibroSpect NASH: multi-marker serum-based test to assess liver fibrosis due to NASHo FibroSpect HCV: multi-marker serum-based test to assess liver fibrosis due to… Show more Assisted with Several Product Launches within the CLIA Lab:o Monitor: serum test to assess the colon of Crohn’s disease patients without an endoscopyo Anser Ustekunimab (STELARA®): Therapeutic Drug and Anti-Drug Monitoring Testo Anser Vedolizumab (ENTYVIO®): Therapeutic Drug and Anti-Drug Monitoring Testo FibroSpect NASH: multi-marker serum-based test to assess liver fibrosis due to NASHo FibroSpect HCV: multi-marker serum-based test to assess liver fibrosis due to HCVo IBcause: multi-marker stool-based test to determine the cause of chronic diarrheaLed the group to create Procise (Novel Platform: Quantitative WB results in <2 min.)o Compatible with 20 µL fingerstick whole blood, serum, plasma, fecal extract and urineo Involved in all aspects of Procise including concept (Marketing), instrument creation, assay development, manufacturing transfer and 510(k) and CE Marko Led the development and assay integration of all assays in production (4-5 assay EU launch in Q2 2020)o US Clinical Trials initiatedo Invented the math and led the software integrationo Shown proof-of-concept for ~20 analytes Show less

Oversaw quantitative assay product development, analytical methods and new product ideation and feasibility in addition to leading the system integration for the Sofia 2 instrument. Interacted with cross functionally throughout the organization and provided biweekly executive updates.Key Achievements:• Created the concept for Sofia 2 • Instrumental in the launch of Sofia 2 and created the Advance Result Technology (ART) algorithm allowing for results in as little as 3… Show more Oversaw quantitative assay product development, analytical methods and new product ideation and feasibility in addition to leading the system integration for the Sofia 2 instrument. Interacted with cross functionally throughout the organization and provided biweekly executive updates.Key Achievements:• Created the concept for Sofia 2 • Instrumental in the launch of Sofia 2 and created the Advance Result Technology (ART) algorithm allowing for results in as little as 3 minutes• Conceptualize and Led Sofia hCG assay through launch and invented the Kinetic Check™ technology used to enhance manufacturability and product performance• Led the quantitative Vitamin D assay through design freeze which later received CE Mark Show less

Oversaw new product development ideation and feasibility in concert with Marketing, the creation and validation of analytical methods and transfer to Quality Control, product support for current Manufacturing products and the creation and management of new platforms (Sofia). Key Achievements:• Led the group that launched the first assay (Influenza A+B) on Sofia with sensitivity 100X visual read and rivaling molecular (FDA clearance in 88 days)• Created the software architecture… Show more Oversaw new product development ideation and feasibility in concert with Marketing, the creation and validation of analytical methods and transfer to Quality Control, product support for current Manufacturing products and the creation and management of new platforms (Sofia). Key Achievements:• Led the group that launched the first assay (Influenza A+B) on Sofia with sensitivity 100X visual read and rivaling molecular (FDA clearance in 88 days)• Created the software architecture and algorithms for Sofia• Showed proof of concept for 15 different assays leading to 5 FDA 510(k) clearances (2 CLIA Waivers) and 8 CE Marks• Worked on QuickVue RSV(10) which received 510(k) and CLIA Waiver• Showed proof of concept on a visually read highly sensitive fluorescent-based platform• Created an Analytical Method Department and established and validated Quality Control methods for all key raw materials for Quidel’s existing and new products• Created New Product Ideation group to research new product offerings and cost savings leading to Quidel’s 10-year product pipeline• Created an Antibody Development group to reduce antibody cost, increase product performance and strengthen the supply chain• Optimized manufacturing processes to enhance yield and reliability for existing processes Show less

Identified and created analytical standards to measure the functionality of biological material and created Reference Standards to normalize the product performance.

I taught the entire General Chemistry series twice with an average class size of 300+ students and 6 teaching assistants. This position allowed me to hone my managerial abilities, increase my personable skills, and enhance my organizational skills. My half-time research focused on the creation of novel chemical weapons sensors able to detect trace amounts of airborne pathogens. Additionally I instructed the entire Analytical Chemistry curriculum: Analytical Chemistry… Show more I taught the entire General Chemistry series twice with an average class size of 300+ students and 6 teaching assistants. This position allowed me to hone my managerial abilities, increase my personable skills, and enhance my organizational skills. My half-time research focused on the creation of novel chemical weapons sensors able to detect trace amounts of airborne pathogens. Additionally I instructed the entire Analytical Chemistry curriculum: Analytical Chemistry Laboratory/Lecture (Chem 100A) and the Instrumentation Laboratory/Lecture (Chem 100B and 100BL). I devised separation and quantitative experiments within both laboratories that utilized both wet-Chemistry and instrumentation. The instrumentation utilized included: HPLC (with UV-Vis, Florescence, and Refractive Index detectors), FTIR, UV-Vis, Florescence, IC, GC (with FID, TCD, MS, and HS), and Flame AA and AE. Show less