Principal Scientist, IVD Reagent Development and Manufacturing

United States·Palo AltoFull-Timelead

OtherManufacturing

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Quick Summary

Overview

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.

Technical Tools

OtherManufacturing

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:

Requirements

~1 min read

PhD with 8+ years or Master’s with 10+ years industry assay/reagent development with experience in Molecular Biology, Biochemistry, Chemistry, or a similar discipline

3+ years of developing IVD diagnostic tests with NGS cfDNA/multi-omic assay technologies from plasma (e.g., DNA fragments, RNA, small variants, methylation, or immunoassays) under 21 CFR Part 820 or ISO 13485.

2+ years of experience developing reagent specifications (format, fill volume tolerance, closure, label, shelf, and in-use stability), reagent integrations with automated platforms, and transferring reagent manufacturing from R&D to an internal department or an external contract reagent manufacturer.

Hands-on with reagent development for IVD or LDT product development experience, working in a regulated laboratory environment (GxP).

Experience in writing protocols, designing experiments, analyzing, and documenting results in reports.

Clear communication skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training junior scientists and other cross-functional stakeholders to foster a collaborative, knowledge-sharing and data-driven culture.

Ability to work on-site at our Palo Alto laboratory three to five days a week when required, with periodic travel to the reagent manufacturer sites for audit purposes.

Nice to Have

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Experience with IVD reagent kitting and reagent interchangeability

Experience in developing reagent QC methods and Process Validation for reagent manufacturing.

Experience in managing R&D relationships and auditing reagent suppliers.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.