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DELFI Diagnostics is developing next-generation, blood-based cancer detection tests using advanced machine learning and whole-genome sequencing. The company's DELFI platform leverages fragmentomics—analyzing patterns in cell-free DNA fragments to identify cancer signatures. FirstLook Lung, their first laboratory-developed screening test, uses millions of data points to identify individuals who may have lung cancer with a 99.8% negative predictive value.
As a Senior Scientist in Assay Development, you will be part of the team driving development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications in early cancer detection. You will report to the Director leading the analytical validation program and contribute to the design, execution, and documentation of design verification studies that form the basis for assay analytical performance claims.
Key responsibilities include:
- Design, develop, and optimize assay, reagent, and quality-control parameters to set tolerance limits and meet performance requirements for complex multiomics assays
- Assist and execute analytical validation (AV) studies, design verification studies, and design transfer activities
- Collaborate with R&D, Lab Operations, Biostatisticians, and Quality/Regulatory teams to execute study plans
- Draft design verification and validation study documentation, including protocols and reports
- Contribute to FDA PMA submission packages under manager guidance
- Prepare data summaries for Formal Design Reviews and key program milestones
- Contribute to design control processes throughout the product lifecycle, including plans, risk assessments, and design verification activities
- Support compliance culture by following and contributing to scalable tools and processes for compliant product development
- Provide technical guidance and mentorship to associate scientists and research associates on validated methods and best practices
This is a lab-based position required to be onsite 5 days per week when needed for laboratory work. DELFI has 1-2 designated in-office working days each week for employees living within 50 miles of Palo Alto, CA or Baltimore, MD offices.
REQUIREMENTS:
Required:
- Doctoral degree in Molecular Biology or related field; OR Master's degree with 2+ years relevant work experience; OR Bachelor's degree with 5+ years relevant work experience; or equivalent
- 2+ years experience developing molecular or genomic assays
- Hands-on NGS assay development experience, ideally with liquid biopsies (genomic and/or multiomics)
- Experience with design of experiments (DOE), assay optimization, and data-driven decision making
- Working knowledge of developing products within a Design Control/regulated environment (FDA 21 CFR Part 820, ISO 14971, ISO 13485, IVDR)
- Strong analytical skills with ability to independently solve complex technical problems and adapt established approaches to new situations
- Proven ability to collaborate cross-functionally and communicate effectively with technical and non-technical stakeholders
Preferred:
- Experience with multiomics assays and integration of multiple omics under one product
- Experience with cfDNA or fragmentomics-based assays
- Exposure to design verification and/or PMA submissions
