Senior Scientist — NGS & Molecular Diagnostics Validation

Yoh, A Day & Zimmermann Company; Sunnyvale (CA); On-site; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical benefits

HSA

401K Retirement Savings Plan

EAP

Certification and training

Job summary

Yoh, a Day & Zimmermann company, seeks a Senior Scientist to lead analytical validation for NGS-based molecular diagnostics in Sunnyvale. The role demands hands-on cfDNA workflow experience, robust NGS library prep knowledge, and expertise in regulated validation environments.

You will design studies, set acceptance criteria, and collaborate across assay development, bioinformatics, automation, quality, and regulatory teams to ensure assay performance and readiness for clinical milestones.

Qualifications

• Ph.D. required in a relevant scientific discipline.
• Hands-on experience with cell-free nucleic acid workflows or low-input molecular assays.
• Strong background in NGS library prep and sequencing workflows.
• Experience designing and executing analytical validation studies for molecular assays or NGS-based products.
• Knowledge of analytical sensitivity/specificity, LoB/LoD/LoQ, precision, and robustness testing.
• Ability to work independently in a multidisciplinary environment.

Responsibilities

• Design and execute analytical validation studies for molecular diagnostic assays and NGS-based testing platforms; develop study designs, acceptance criteria, sample size calculations, and statistical analysis plans.
• Lead validation studies covering LoB, LoD, LoQ, analytical sensitivity/specificity, repeatability, reproducibility, and variability assessments.
• Identify assay failure modes and implement corrective actions to improve performance.
• Perform and optimize workflows for plasma processing, cfDNA extraction, quantification, and quality assessment.
• Develop and qualify controls, reference materials, and test specimens for validation studies.
• Support characterization of low-abundance molecular signals and assay sensitivity limits.
• Operate and troubleshoot NGS instrumentation; analyze sequencing metrics and collaborate with bioinformatics teams.
• Generate technical summaries, validation reports, and performance assessments.
• Partner with automation engineers to transfer workflows to automated platforms; support workflow qualification and scale-up.
• Author validation protocols, reports, deviation investigations, and documentation in regulated environments.

Skills

Molecular biology

Analytical rigor

Statistical thinking

NGS workflows

Regulated assay development

Education

Ph.D. in Molecular Biology, Genetics, Genomics, Biochemistry, Bioengineering

Job description

Yoh, a Day & Zimmermann company, seeks a Senior Scientist to lead analytical validation for NGS-based molecular diagnostics in Sunnyvale. The role demands hands-on cfDNA workflow experience, robust NGS library prep knowledge, and expertise in regulated validation environments.

You will design studies, set acceptance criteria, and collaborate across assay development, bioinformatics, automation, quality, and regulatory teams to ensure assay performance and readiness for clinical milestones.