Principal Assay Development Scientist (Reagent)
Principal Assay Development Scientist (Reagent)
Posted on :
30-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
30-08-2025
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 Development Scientist you will play a critical role in developing in vitro diagnostic (IVD) reagents by establishing reagent specifications transferring reagents to contract reagent manufacturers and managing R&D relationships with vendors. Once reagents are established this role will also contribute to other assay development activities for DELFIs molecular diagnostic assays. The ideal candidate will have a strong scientific foundation in Next-Generation Sequencing (NGS) with liquid biopsies technical leadership and experience working under a Design Control framework to develop and validate regulated diagnostic products. This is a lab-based position that requires being on-site up to 5 days a week when needed.
What youll do
- Lead the IVD reagent development plan execution by developing reagent specifications for finished reagents that will be used for DELFIs molecular diagnostic assays.
- Define reagent criticality (key ancillary general use) for DELFIs molecular diagnostic assays and develop appropriate manufacturing and QC methods to conform to 21 CFR Part 820 ISO 1384 and CAP CLIA by collaborating closely with Quality and Regulatory.
- Evaluate Contract Reagent Manufacturers to transfer the reagents manufacturing. Be the primary point of contact and accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements.
- Establish R&D relationships with different vendors and participate in Quality audits.
- Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.
- Perform rigorous design of experiment data analysis and act as subject matter expert by collaborating with assay biostatisticians bioinformaticians engineers and scientists. Participate in laboratory on-site work when required.
- Maintain reagent development plan develop reagent FMEA and contribute to other design documents such as protocols and reports under Design Control to meet product development and project milestones.
What youll have accomplished 12 months from now
- Successful execution of the reagent development plan and transfer of reagent manufacturing to a contract reagent manufacturer.
- 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 7 years or Masters 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).
- 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 and assay optimization for 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 to foster 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 with periodic travel to the reagent manufacturer sites for audit purposes.
- Preferred
- 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.
$150000 - $185000 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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