Manager, Assay Development at Myriad Genetics / Gateway Genomics (2021-05 – Present)
Hands-on molecular assay development, analytical and clinical validation, technology transfer, and technical support for regulated diagnostic laboratory workflows, with one direct report.
- Lead analytical verification and validation strategy for molecular diagnostic workflows, independently defining study plans, acceptance criteria, experimental approaches, and data-analysis methods across accuracy/concordance, precision/reproducibility, analytical sensitivity, robustness, stability, equivalency, interference, and workflow variability.
- Lead development and validation of a direct-from-plasma qPCR LDT from feasibility through ~2,000-sample analytical validation, technology transfer, and clinical laboratory implementation; reduced plasma input by 90% and processing time by 50%.
- Named inventor on a provisional patent related to extraction-free molecular assay development and direct-from-plasma testing.
- Contribute to NGS assay development and validation across multiple concurrent prenatal testing and MRD programs, leading defined wet-lab workstreams in extraction and quantification optimization, process guardbanding, workflow characterization, and evaluation of variables affecting library yield, quality, and downstream performance.
- Lead feasibility, clinical evaluation, comparative validation, and implementation of FDA-cleared capillary blood-collection devices, including ~200-sample clinical and ~200-sample comparative studies; authored protocols, SOPs, technical reports, change documentation, and technical evidence supporting CE-mark requirements.
- Identified and resolved post-launch assay-performance trends through structured investigation of reagent, control, instrumentation, operator, and workflow variables, improving the production inconclusive rate by ~2 percentage points and enabling approximately 6,000 additional reportable samples annually.
- Serve as technical lead for cross-functional scientific activities with Clinical, Bioinformatics, Quality, Regulatory, Laboratory Operations, Product, Engineering, and external partners, present and defend experimental findings and translate data into technical recommendations, validation decisions, and implementation plans.
- Technically mentor Assay Development scientists and laboratory staff in experimental design, study execution, troubleshooting, data interpretation, documentation, and scientific communication; directly manage one scientist and co-supervise laboratory staff during validation and transfer activities.
Scientist at Abbott Rapid Diagnostics (2020-07 – 2021-06)
COVID-19 rapid diagnostics program
- Supported development, optimization, validation, and transfer of molecular QC assays for NEAR isothermal-amplification enzymes used in COVID-19 rapid diagnostics within a cGMP-regulated manufacturing and quality environment.
- Partnered with R&D, Manufacturing, QC, and site teams on assay transfer, enzyme-production quality testing, technical investigations, and production-site relocation; coordinated technical milestones, trained employees, and applied JMP and R to assay and manufacturing-quality data.
Scientist at Juno Diagnostics (2019-01 – 2020-06)
- Optimized an Illumina-based microvolume NGS/NIPT workflow for clinical cfDNA specimens, including development of automated microvolume plasma extraction protocols on the Eppendorf epMotion platform, sample preparation, library workflow optimization, sequencing assay development, and analytical performance evaluation.
- Executed development and validation studies across blood-based workflows, analyzing experimental and assay-performance data to identify performance-limiting variables and guide assay and process optimization.
- Contributed to development and clinical evaluation of the first FDA-cleared at-home blood-collection device capable of separating plasma from whole blood, enabling improved preservation of nucleic-acid components during sample transport; supported device stability, usability, accuracy, and integration with downstream molecular workflows.
Research Associate / Research Program Supervisor at University of Szeged (2011-09 – 2018-09)
- Conducted and supervised multidisciplinary research spanning molecular biology, protein expression and purification, pharmaceutical analytics, computational analysis, and experimental-method development.
- Mentored undergraduate researchers in study design, laboratory execution, data analysis, interpretation, and scientific communication; one mentee won a national student research competition, and authored/coauthored instructional materials in pharmaceutical analysis and biotechnology.
