Scientist

Department

Research & Development (R&D)

Summary

nRichDX is seeking an R&D team member whose primary responsibility will be quality control and functional testing of nucleic-acid extraction kits (cfDNA/cfRNA/cfTNA/CTC-related), supporting product releases and manufacturing scale. This role will also contribute to routine R&D workflows, including method verification, troubleshooting, documentation, and data generation for continuous improvement and external deliverables.

Key Responsibilities

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.

Qualifications

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.

Preferred

• Experience with cfDNA/cfRNA/cfTNA workflows, low-input samples, or liquid biopsy.
• Experience with TapeStation/Bioanalyzer, NGS library QC, or inhibition/contamination control strategies.
• Familiarity with GxP/ISO concepts, change control, deviations, and data integrity principles.
• Experience supporting automation platforms (Hamilton, etc.).
• Comfortable analyzing data in Excel; bonus for basic stats/graphing or scripting.

Skills & Attributes

• Highly organized, reliable, and execution-focused.
• Strong troubleshooting mindset and ability to identify patterns/trends across lots.
• Collaborative and comfortable working with R&D, Manufacturing, and Quality.
• Able to manage multiple tests/priorities while maintaining accuracy.

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.