Scientist​/Senior Scientist

Yoh is seeking a Senior Scientist, Analytical Validation – NGS & Molecular Diagnostics for an exciting opportunity with an innovative biotechnology client in the South Bay Area.

This role will be responsible for designing, executing, analyzing, and documenting analytical validation studies supporting advanced molecular diagnostic and next-generation sequencing (NGS) assays. The successful candidate will play a key role in establishing assay performance, reproducibility, robustness, and readiness for future clinical and regulatory milestones.

We are looking for a scientist who combines strong molecular biology expertise with analytical rigor, statistical thinking, and hands-on experience in cell-free nucleic acid workflows, NGS technologies, and regulated assay development environments.

Department:
Assay Development / Research & Development.

Location:

Sunnyvale, CA.

Employment Type:

Full-time. Salary: $160,000 - $220,000 (DOE).

• Analytical Validation Strategy & Execution
  • Design and execute analytical validation studies for molecular diagnostic assays and NGS-based testing platforms.
  • Develop scientifically sound study designs, acceptance criteria, sample size calculations, and statistical analysis plans.
  • Lead studies evaluating:
    • Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ), as applicable
    • Analytical sensitivity and specificity
    • Repeatability and reproducibility
    • Operator, instrument, reagent lot, and workflow variability
    • Method comparison and analytical agreement
    • Interference, contamination, carryover, and assay robustness
    • Specimen and reagent stability
  • Identify assay failure modes and implement corrective actions to improve performance and reliability.
• Molecular Biology & NGS Assay Development
  • Perform and optimize workflows involving plasma processing, cell-free nucleic acid extraction, quantification, and quality assessment.
  • Execute NGS library preparation workflows including:
    • End repair
    • Adapter ligation
    • Indexing
    • Amplification
    • Target enrichment
    • Library quality control
  • Evaluate the impact of DNA input quantity, library efficiency, sequencing depth, and molecular background noise on assay performance.
  • Develop and qualify controls, reference materials, and test specimens for validation studies.
  • Support characterization of low-abundance molecular signals and assay sensitivity limits.
• NGS Data Analysis & Performance Assessment
  • Operate and troubleshoot NGS instrumentation and associated workflows.
  • Analyze sequencing and library quality metrics, including:
    • Read depth
    • Coverage uniformity
    • Mapping performance
    • Library complexity
    • Duplication rates
    • On-target performance
  • Collaborate with bioinformatics teams to evaluate analytical pipeline performance and quality-control thresholds.
  • Perform statistical analyses using tools such as R, Python, JMP, SAS, or equivalent platforms.
  • Generate technical summaries, validation reports, and performance assessments.
• Automation & Workflow Optimization
  • Partner with automation engineers to transfer molecular workflows onto automated liquid-handling platforms.
  • Evaluate variability introduced by automation and support workflow qualification activities.
  • Assess contamination control strategies, sample tracking systems, and recovery procedures.
  • Support high-throughput laboratory process development and operational scale-up.
  • Contribute to SOP development, troubleshooting guides, and workflow documentation.
• Quality & Regulatory Support
  • Author validation protocols, reports, deviation investigations, and technical documentation.
  • Maintain traceable documentation for samples, instrumentation, reagents, software, and analytical methods.
  • Support quality-system initiatives and documentation practices consistent with regulated laboratory environments.
  • Collaborate with Quality and…