Staff Scientist, Assay Development
Staff Scientist, Assay Development
Posted on :
14-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
14-08-2025
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.
DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices
As a Senior or Staff Development Scientist you will be part of the Assay Development team for the product development of Delfi Diagnostics Lung Cancer Screening Test medical device. You will play a critical role in leading the development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications. The ideal candidate will have a strong scientific foundation in Next-Generation Sequencing (NGS) with liquid biopsies for genomic and proteomic technical leadership and experience working under a Design Control framework to develop and validate regulated diagnostic products. This is a lab based position with some hybrid flexibility. This role is expected to be onsite 5 days a week when needed for laboratory work.
What youll do
- Design develop optimize assay reagent and quality control parameters to set tolerance limits and meet performance requirements for complex multiomic assays.
- Develop robust processes for reagent manufacturing reagent QC and transfer to contract reagent manufacturers.
- Perform rigorous design of experiment data analysis and act as subject matter expert by collaborating with assay biostatisticians bioinformaticians engineers and scientists to determine key assay performance characteristics.
- Document product development requirements and author study protocols and reports to ensure traceability and compliance with industry standards
- Be accountable for development activities and advance the assay through design control processes to meet product requirements and project milestones by contributing to plans risk assessment and verification activities.
What youll have accomplished 12 months from now
- Led the identification of critical to quality parameters optimization and development of specification limits to control the assay and reagent manufacturing processes.
- Be the subject matter expert for Delfi Diagnostics Lung Cancer Screening Test key performance metrics across multiple subsystems and the integration of multiple omics under one medical device.
- Be able to understand regulatory requirements perform risk assessments and participate in the elaboration of plans and data-driven decisions to prioritize IVD development.
What youll bring to DELFI
- Required
- PhD with 5 years or Masters with 8 years industry assay development experience experience in Molecular Biology Biochemistry Chemistry or a similar discipline.
- Deep understanding of developing NGS cfDNA/multi-omic assay technologies from plasma (e.g. DNA fragments RNA small variants methylation and immunoassays).
- Hands-on with reagent development and assay optimization with IVD or LDT product development experience working in a regulated laboratory environment (GLP).
- 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 fostering a collaborative knowledge-sharing and data-driven culture.
- Ability to work on-site at our Palo Alto laboratory five days a week when required to be hands-on in the laboratory and travel to the Baltimore office periodically.
- Preferred
- Experience validating or establishing key performance characteristics such as LoB LoD LoQ and linearity for quantitative assays.
- Experience establishing sample intermediates safe stopping points reagent shelf life and in-use reagent stability specifications.
- Data analysis capabilities using languages such as R Python or JMP.
- Developing or executing assays using automated liquid handlers is preferred.
- Product transfer in a regulated and/or ISO-compliant environment
$125000 - $175000 a year
Total Compensation at DELFI is a combination of salary bonus equity and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skillset years & depth of experience certifications & relevant education geography.
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.
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.
Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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