Staff Scientist, IVD Assay Verification and Validation

DELFI Diagnostics•Palo Alto, CA

About The Position

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. In our passionate pursuit to radically improve health outcomes, we serve humanity when we: Lead with Science, Anchor in Pragmatism : We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction. Build With & For All : We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class Put We over I : We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey. About this role In this role, you will support the verification and validation of an automated IVD Next-Generation Sequencing-based assay under development for early cancer detection. Reporting directly to the Principal Scientist leading the analytical validation (AV) 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.

Requirements

Doctoral degree in Molecular Biology, or a related field with 4+ years of relevant work experience; or Master’s degree with 7+ years of relevant work experience; or Bachelor’s degree with 9+ years of relevant work experience; or equivalent.
2+ years of experience developing IVD products in regulated environments
Working knowledge of IVD regulatory requirements (FDA 21 CFR Part 820, ISO14971, ISO13485, IVDR).
Hands-on IVD and analytical validation experience with genomic or multi-marker ‘omic assays.
Strong analytical skills with the ability to solve complex technical problems.
Proven ability to collaborate cross-functionally and communicate effectively with technical and non-technical stakeholders.

Nice To Haves

Experience with design transfer and/or manufacturing of IVD products.
Exposure to or direct participation in PMA submissions.

Responsibilities

Support Delfi’s culture of compliance by contributing to scalable tools, structures, and processes for compliant product development.
Assist in the verification and validation of products compliant with CLIA, FDA, and international regulatory standards, under the direction of the Principal Scientist.
Contribute to the execution of Delfi’s design control process throughout all stages of the product life cycle.
Design, plan, and execute analytical validation (AV) studies, other design verification studies, and design transfer activities as assigned by the Principal Scientist.
Collaborate with R&D, Lab Operations, Biostatisticians, and Quality and Regulatory teams to execute study plans.
Prepare design verification and validation study documentation, including study protocols and reports.
Contribute to FDA PMA submission packages under the guidance of the Principal Scientist.
Prepare and present data at Formal Design Reviews and key program milestones.
Collaborate with Systems Engineering to document product requirements and support design verification activities that confirm requirements are met.