Development Scientist
Listed on 2026-10-16
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager -
Research/Development
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) SummarynRichDX 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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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