Scientist

Kit QC & Functional Testing (Primary): Own and execute functional testing plans for commercial kit lots (incoming components, in-process, and final kit performance testing).Run routine QC assays, including (as applicable): qPCR/RT-qPCR (recovery, inhibition checks, linearity) TapeStation/Bioanalyzer (size profiles, integrity, yield QC) Fluorometric quantification (Qubit/PicoGreen/RiboGreen) Extraction performance checks (yield, reproducibility, carryover, contamination controls) Prepare and process biological samples (plasma/urine/whole blood and contrived controls) according to SOPs. Track lot performance, generate QC summaries/CoA-support data, and flag out-of-spec trends. Investigate deviations and failures, perform root-cause analysis, and recommend corrective actions with R&D, Manufacturing, and Quality.

Cross-Functional Support: Partner with Manufacturing to ensure smooth tech transfer and readiness for scale (materials, build records, test readiness).Coordinate with Quality on documentation, change control support, and release criteria. Support troubleshooting of customer-reported issues by recreating conditions and documenting findings.

Routine R&D Work (Secondary): Assist with protocol optimization, method verification, and robustness studies. Support automation workflows as needed (e.g., Hamilton or internal platforms), including run setup, execution, and data review. Maintain lab organization, instrument upkeep, reagent preparation, and inventory management. Maintain high-quality documentation: lab notebooks, raw data files, SOP updates, and summary reports.

Required: B.S. in Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, or related field (M.S. preferred).2+ years hands-on experience in a molecular biology lab (industry preferred).Demonstrated experience with DNA/RNA extraction and qPCR/RT-qPCR.Strong attention to detail and comfort working in a structured, repeatable testing environment. Ability to produce clear documentation and communicate results to cross-functional teams.

Working Conditions: Lab-based role handling human-derived specimens (with appropriate training and PPE).May require occasional schedule flexibility to support builds, releases, or time-sensitive studies. Success Metrics (First 3–6 Months):Independently executes the functional testing plan for kit lots with minimal supervision. Produces consistent, audit-ready QC documentation and summaries. Helps reduce retests/failures via early detection of issues and clear root-cause investigations. Contributes meaningfully to routine R&D studies and continuous improvement efforts.