Providing veterinary diagnostic support to the Delmarva poultry industry.

Lead scientist, independently developing GLP immunoassays to selectively measure and quantitate Ig isotypes against AAV capsids in Human serum pre- and post-dosing with AAV gene therapies. Lead scientist leveraging newly development immunoassays to uncover and interpret patterns in human immunology that will impact the way we select patients for enrollment in gene therapy clinical trials. Fast-paced and high-impact project with stakeholders at the executive level. Responsibilities include independent experimental design, execution of experiments, data analysis, data representation, and data and project presentation.

Assay development and sample testing to support preclinical and clinical studies for AAV-based gene therapies. Troubleshooting and continuous improvement of cell-based, transduction-inhibiting (NAb) assays to support selection of NHPs with low neutralizing Ab titers against AAV capsids. Development of bioanalytical methods to measure transgene expression in NHPs pre- and post-dosing with AAV gene therapies by qPCR, Western blotting, ELISA, or ECLIA. Extensive development of immunoassays to selectively measure Ig isotypes against AAV capsids in NHPs pre- and post-dosing with AAV gene therapies to support interpretation of transgene expression results. Development and validation of GLP activity assays to measure activity of therapeutic protein delivered by AAV vector in rodents, NHPs and Humans.

Research and development of cell based GMP test methods for identity, purity, potency and safety testing of viral vector derived cell and gene therapy drug products. Drafting, qualification and validation of GMP test methods and Client Protocols to be used by Virology testing services. Providing training to Virology testing technicians for new test methods. Providing training to new department personnel for use of the REES Environmental Monitoring System. Compliance with SOPs and GDPs. Laboratory maintenance and supply ordering.

Performance of cell based assays for the detection of viral contaminants in cell and gene therapy drug products and manufacturing materials. Compliance with GMP and GLP regulations, SOPs, and GDP standards. Assays included but were not limited to PCR, ELIZA, Plaque Assay for PFU, TCID50, IFA, FAID50, Ultracentrafuge for SEM, and Cell Banking. Played an important role in laboratory maintenance and process improvement.

Worked closely with graduate level personnel to complete project and co-author a paper on molecular characterization of mouse, lens, epithelial cell lines. Performed and troubleshot molecular biology methods including cell culture, DNA isolation, PCR, Agarose Gel Electrophoresis, Real-Time qRT-PCR, and IFA. Helped to maintain lab's stock supply of wild type mouse tissue samples.