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Development Scientist

Job in Irvine, Orange County, California, 92713, USA
Listing for: nRichDX Inc.
Full Time position
Listed on 2026-10-16
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist - Analyst/Manager
  • Research/Development
Salary/Wage Range or Industry Benchmark: 85000 - 120000 USD Yearly USD 85000.00 120000.00 YEAR
Job Description & How to Apply Below

We are a pioneering liquid biopsy company dedicated to advancing non‑invasive diagnostic technologies. Our mission is to enable early disease detection and monitoring through cutting‑edge molecular biology techniques. We are seeking a motivated Scientist to join our dynamic team and contribute to our innovative solutions in liquid biopsy.

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):
  • Tape Station/Bioanalyzer (size profiles, integrity, yield QC)
  • 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 of 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 automation, liquid handlers such as Hamilton Star.
  • Experience with cfDNA/cfRNA/cfTNA workflows, low‑input samples, or liquid biopsy.
  • Experience with Tape Station/Bioanalyzer, NGS library QC, or inhibition/contamination control strategies.
  • Familiarity with GxP/ISO concepts, change control, deviations, and data integrity principles.
  • 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.
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