Scientist
CurrentClinical Support and Validation Lead (Jan 2021 – Present)• Manage a team of scientists supporting clinical trials for TruSight Oncology Comprehensive• Primary Liaison between the Product Development/R&D, Clinical Affairs, Field Support, and Commercial Training teams to ensure clinical trial success in support of U.S. and Global regulatory registration• Coordinate activities for Service team training (FSE/FAS), clinical site equipment installations, site operator training and proficiency• Lead cross-functional technical complaint handling meetings during clinical trial execution, drive short and long term resolutions to issues observed during trials• Ensure user guides and field service documentation incorporate feedback from clinical testing• Lead the design, execution and documentation of end to end system validation testingProduct Development (Jan 2013 – January 2021)• Contribute to the development of a whole genome sequencing solution for rare and undiagnosed diseases; primary role was library prep optimization/characterization and workflow integration with the NovaSeq6000 Dx.• Lead integration of wet lab, bioinformatics and software for a multiplex PCR transplant monitoring assay.• Collaborate with external sites to gain voice of customer, identify key technical risks early in the development process, and ensure must have features are incorporated before product release.• Subject matter expert for TruSight HLA – significant contributions include creation of the validation sample panel and sample sheet template. • Conduct hands on wet lab training for customers and Illumina field representatives.• Generate internal and external facing documents (product guides, templates, work instructions, engineering reports, specification sheets).• Lab management (Pre-PCR, Post-PCR, BSL2).