Clinical Laboratory Scientist (Contract)

Job Description

Job Description

About Us

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.

In this contract role, you will be responsible for performing high complexity laboratory testing for cancer detection via next generation sequencing. You will work closely with automation, assay development and technology transfer scientists to build scalable infrastructure within the Clinical Laboratory. You will be part of a cross-functional team working to launch products for clinical use.

• Perform laboratory tests, procedures, analyses, and reporting of patient results per approved procedures
• Identify and troubleshoot high complexity problems that may adversely affect the test performance
• Perform and document reagent manufacturing and qualification per approved procedures
• Verify instrument performance through inspection, calibration, and maintenance per approved procedures
• Organize and conduct the training of new and existing laboratory personnel on current and new procedures
• Manage laboratory equipment, including coordinating installation, qualification, calibration, preventive maintenance, troubleshooting, and repair activities to ensure equipment performance, reliability, and compliance with approved procedures.

• Must possess an active and valid Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California pursuant to Division 2, Chapter 3 of the California Business and Professions Code or to practice medicine, osteopathy, or podiatry pursuant to Division 2, Chapter 5 of the California Business and Professions Code appropriate to the specialty being performed
• Must fulfill requirements stated in 42 CFR 493.1489 or 493.1491
• Must fulfill requirements stated in the College of American Pathologists Molecular Pathology Checklist
• BS in Biomedical Laboratory Sciences, Clinical Science, or equivalent
• Ability to communicate complex technical results to a cross-functional audience
• Desire to learn about cancer genetics and contribute to a diverse, collaborative and mutually respectful working environment
• 2+ years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience
• Laboratory experience within the last year
• Experience with next generation sequencing, molecular biology techniques and automated liquid handlers
• Working knowledge of local, state, and federal laboratory regulations