Senior Scientist, Multiomics NGS Assay Development

DELFI Diagnostics; Palo Alto (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

DELFI Diagnostics, Inc. is seeking a senior Assay Development Scientist to drive development and optimization of multiomics molecular diagnostic assays for early cancer detection.

The role reports to the Director of Analytical Validation and involves designing verification studies and documenting results for regulatory submissions. You’ll work onsite, collaborating with QA, Regulatory, Biostatistics, and R&D teams to ensure design control, risk management, and high-quality data generation.

Qualifications

• PhD in Molecular Biology or related field, or Master's with required experience, or Bachelor's with 5+ years experience.
• 2+ years experience developing molecular or genomic assays.
• Hands-on NGS assay development experience, ideally with liquid biopsies.
• Experience with DOE, assay optimization, and data-driven decision making.
• Working knowledge of regulated environments (FDA 21 CFR Part 820, ISO 14971, ISO 13485).

Responsibilities

• Design, develop, and optimize assay, reagent, and QC parameters to meet performance requirements.
• Assist and execute analytical validation and verification studies.
• Collaborate with R&D, Lab Ops, Biostatistics, QA, and Regulatory teams.
• Draft study protocols and reports for design verification/validation.
• Contribute to FDA PMA submissions under guidance.
• Prepare data summaries for design reviews and milestones.
• Support design control processes across the product lifecycle.
• Provide guidance and mentorship on validated methods.

Skills

Molecular biology

NGS assay development

Liquid biopsy

DOE

Regulatory environment

Cross-functional collaboration

Data analysis

Communication

Analytical thinking

Education

PhD in Molecular Biology

Master's with 2+ years

Bachelor's with 5+ years

Job description

DELFI Diagnostics, Inc. is seeking a senior Assay Development Scientist to drive development and optimization of multiomics molecular diagnostic assays for early cancer detection.

The role reports to the Director of Analytical Validation and involves designing verification studies and documenting results for regulatory submissions. You’ll work onsite, collaborating with QA, Regulatory, Biostatistics, and R&D teams to ensure design control, risk management, and high-quality data generation.