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Palo Alto, California, United States
Hybrid
In this role, you will be part of the Assay Development team driving the development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications for early cancer detection. Reporting to the Director leading the analytical validation program, you will contribute to the design, execution, and documentation of design verification studies that will serve as the basis for the assay’s analytical performance claims. You will collaborate closely with quality and regulatory functions to help ensure that product design, development, and transfer comply with design control and risk management requirements.You will apply a strong foundation in Next-Generation Sequencing (NGS) and liquid biopsies, working within a Design Control framework to develop and validate regulated diagnostic products. This is a lab-based position that is required to be onsite when needed for laboratory work
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.
Provide technical guidance and mentorship to associate scientists and research associates on validated methods and best practices.
Required
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.
Preferred
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.
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