Senior Scientist, Assay Development

DELFI Diagnostics•Palo Alto, CA

1d•Onsite

About The Position

DELFI Diagnostics is developing next-generation, blood-based tests for early cancer detection using advanced machine-learning methods and fragmentomics. The DELFI platform analyzes cell-free DNA (cfDNA) fragments to identify cancer. Their first product, FirstLook Lung, is for individuals eligible for lung cancer screening. The company values leading with science, building with and for all, and prioritizing teamwork. This role is part of the Assay Development team, focusing on developing and optimizing robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications. The position reports to the Director leading the analytical validation program and involves contributing to design verification studies, collaborating with quality and regulatory teams, and working within a Design Control framework for regulated diagnostic products. This is a lab-based position that requires being onsite when needed for laboratory work, with an expectation of being onsite 5 days a week when laboratory work is required.

Requirements

Doctoral degree in Molecular Biology or a related field; or Master's degree with 2+ years of relevant work experience; or Bachelor's degree with 5+ years of relevant work experience; or equivalent.
2+ years of 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 the 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.

Nice To Haves

Experience with multiomics assays and the integration of multiple omics under one product.
Experience with cfDNA or fragmentomics-based assays.
Exposure to design verification and/or PMA submissions.

Responsibilities

Design, develop, and optimize assay, reagent, and quality-control parameters to set tolerance limits and meet performance requirements for complex multiomic assays.
Assist and execute analytical validation (AV) studies, other design verification studies, and design transfer activities as assigned by your manager.
Collaborate with R&D, Lab Operations, Biostatisticians, and Quality and Regulatory teams to execute study plans.
Draft design verification and validation study documentation, including study protocols and reports, for review.
Contribute to FDA PMA submission packages under the guidance of your manager.
Prepare data summaries for Formal Design Reviews and key program milestones.
Contribute to Delfi's design control process throughout the product life cycle, including plans, risk assessments, and design verification activities, to advance the assay toward product requirements and milestones.
Support Delfi's culture of compliance by following and contributing to scalable tools, structures, and processes for compliant product development.
Provide technical guidance and mentorship to associate scientists and research associates on validated methods and best practices.