Karen L. Email & Phone Number

Durham, North Carolina, United States

Durham, North Carolina, United States

Durham, North Carolina, United States

Raleigh-Durham, North Carolina Area

Molecular Diagnostics R&D - Develop and validate infectious disease molecular diagnostic assays on the BD MAX platform• Primary and leadership role in the design, optimization, verification and validation of the FDA cleared/CE Mark certified BD MAX™ Enteric Parasite Panel (EPP), managed clinical specimen inventory and testing during EPP clinical trial.• Led the design and execution of key performance verification studies in support of the FDA approved/CE Mark certified BD MAX™ Vaginal Panel.• Leadership role for claim extension to add a new sample type to the BD MAX™ Enteric Suite for use with automation. Developed equivalency testing procedure, authored and performed procedures for bacterial stock growth and qualification including stock enumeration using BD Accuri™ C6 Plus flow cytometer.• Collaboration with cross-functional teams for the development of a new consumable that will increase sensitivity of the BD MAX™. Key contact for BD MAX™ Product Support and Operations for product troubleshooting and evaluations. • Execute intricate experimental design (DOE), analyze complex data using statistical analysis and present using visual display the findings to cross-functional teams. Skilled in Microsoft Office Tools (Word, Excel, PowerPoint) and Minitab.• Managed laboratory including equipment purchase and evaluation, space planning, inventory management, mentoring and training junior scientists.

• Antibody development, characterization and assay design in support of multiple diagnostic product development projects.• Responsible for antibody characterization, assay development, and modification in ELISA, Western blot, and bead-based assays for in-house projects. Performed all limit dilution cloning and hybridoma candidate scale-up. Improved cloning efficiency by utilizing flow cytometry in the cloning procedure (FACSAria™).• Developed antibody pairs ELISA assays for multiple cancer and infectious disease antigens. Responsible for antibody pairs testing and selection of candidates for further assessment for projects outside division. Continually worked to improve the pairs assay.

• Developed, isolated, and scaled-up monoclonal antibodies for use in the development of cancer diagnostic kits.• Assisted with RIMMS (Rapid Immunizations Multiple Sites) on mice, a technique that improves the speed and diversity of hybridomas generated relative to conventional techniques, and somatic fusions for the development of "polydoma".• Performed limit dilution cloning to capture relevant hybridoma and media adaptation and scale-up of product hybridoma candidates.

• Fermentation of recombinant Baculovirus infected insect cell lines (Sf9, Tni) in 2L – 100L bioreactors.• Production and titering of Baculovirus stocks.• Scaled up and harvested hybridoma stocks.• Coordinated schedules, equipment, and personnel.

• Lead Research Technician for development of USDA approved vaccines APPtitude™ TX (Actinobacillus pleuropneumoniae) and Myco Silencer® MEH (Haemophilus parasuis).• Optimized parameters for bacterial growth, developed vaccine QC ELISA and designed production procedures including bacterial fermentation, cell washing, and hollow fiber concentration. Transferred procedures to QC and Production.• Bacterial isolation, identification, and diagnosis by ELISA and FA.• Planned, organized and performed animal studies to test research vaccines. Interpreted and analyzed data. • Trained new employees and troubleshoot on co-worker's projects.• Assisted in animal work (swine, mice, rabbits, chickens, and guinea pigs) including vaccination, challenge, necropsy, and organ harvesting.• Developed and improved diagnostic immunoassays. Performed necropsies and retrieved samples for observation and isolation.

• Performed quality testing for a wide variety of microbiological diagnostic products.• Maintained QC bacterial stock cultures (250 organisms – bacteria, fungus, and mycoplasma) –responsible for maintaining sterility and identifying by sight and smell.• Developed QC technical manual.