Senior Scientist, Multiomics Assay Development (NGS)

DELFI Diagnostics, Inc.; Palo Alto (CA); On-site; USD 130,000 - 155,000; Full time

Job summary

DELFI Diagnostics, Inc. is seeking an experienced Assay Development professional to advance multiomics diagnostic assays. The role focuses on design verification, analytical validation, and regulatory submissions, with onsite lab work and collaboration across R&D, Quality, and Regulatory teams.

You will apply a strong foundation in NGS and liquid biopsy concepts to deliver robust, compliant diagnostic products, reporting to the Director of Analytical Validation.

Qualifications

• PhD in Molecular Biology or related field, or equivalent mix of education and experience.
• 2+ years of experience developing molecular/genomic assays and NGS.
• Experience with DOE, assay optimization, and data-driven decisions.
• Experience in Design Control / regulated environment (FDA/ISO).

Responsibilities

• Design, develop, and optimize multiomic assays and QC parameters.
• Perform analytical validation studies and design transfer activities.
• Collaborate with R&D, Lab Ops, Biostatistics, and Quality teams.
• Draft study protocols and reports for verification/validation.
• Contribute to FDA PMA submissions and risk assessments.
• Provide data summaries for design reviews and milestones.
• Support compliant product development with scalable tools and processes.
• Mentor associate scientists and research staff.

Skills

NGS assay development

Fragmentomics

Design of experiments

DOE

Regulated product development

Education

Doctoral degree in Molecular Biology

Master's degree + 2+ years experience

Bachelor's degree + 5+ years experience

Tools

Design control systems

FDA 21 CFR Part 820 awareness

ISO 14971 / ISO 13485 familiarity

Job description

DELFI Diagnostics, Inc. is seeking an experienced Assay Development professional to advance multiomics diagnostic assays. The role focuses on design verification, analytical validation, and regulatory submissions, with onsite lab work and collaboration across R&D, Quality, and Regulatory teams.

You will apply a strong foundation in NGS and liquid biopsy concepts to deliver robust, compliant diagnostic products, reporting to the Director of Analytical Validation.