Senior Scientist, Assay Development

Socket.dev; Palo Alto (CA); On-site; USD 150,000 - 195,000; Full time

Job summary

DELFI Diagnostics, Inc. is seeking an Assay Development specialist to drive development and optimization of multiomics molecular diagnostic assays for early cancer detection. This lab-based role is onsite when needed and reports to the Director of the analytical validation program.

You will collaborate with quality and regulatory teams, apply NGS and liquid biopsy expertise within a Design Control framework, and help advance the assay toward product requirements and milestones.

Qualifications

• Doctoral degree in Molecular Biology or a related field, or Master’s with 2+ years of relevant work experience; or Bachelor’s with 5+ years of relevant work experience.
• 2+ years of experience developing molecular or genomic assays.
• Hands-on NGS assay development experience, ideally with liquid biopsies.
• Experience with design of experiments (DOE), assay optimization, and data-driven decision making.
• Working knowledge of developing products within a Design Control / regulated environment (FDA 21 CFR Part 820, ISO 14971, ISO 13485, IVDR).
• Strong analytical skills with the ability to independently solve complex technical problems and adapt established approaches to new situations.
• Proven ability to collaborate cross-functionally and communicate effectively with technical and non-technical stakeholders.

Responsibilities

• Design, develop, and optimize assay, reagent, and quality-control parameters to set tolerance limits and meet performance requirements for complex multiomic assays.
• Assist and execute analytical validation studies and design transfer activities.
• Collaborate with R&D, Lab Operations, Biostatisticians, and Quality and Regulatory teams to execute study plans.
• Draft design verification and validation study documentation, including protocols and reports.
• Contribute to FDA PMA submission packages under the guidance of your manager.
• Prepare data summaries for Formal Design Reviews and key program milestones.
• Contribute to Delfi's design control process throughout the product life cycle, including plans, risk assessments, and design verification activities.
• Provide technical guidance and mentorship to associate scientists and research associates on validated methods and best practices.

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:

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 50 miles of Palo Alto CA or Baltimore MD offices

In this role, you will be part of the Assay Development team driving the development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications for early cancer detection. Reporting to the Director leading the analytical validation 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. You will apply a strong foundation in Next-Generation Sequencing (NGS) and liquid biopsies, working within a Design Control framework to develop and validate regulated diagnostic products. This is a lab-based position that is required to be onsite when needed for laboratory work

This role is expected to be onsite 5 days a week when needed for laboratory work.

What you’ll do

• Design, develop, and optimize assay, reagent, and quality-control parameters to set tolerance limits and meet performance requirements for complex multiomic assays.

• Assist and execute analytical validation (AV) studies, other design verification studies, and design transfer activities as assigned by your manager.

• Collaborate with R&D, Lab Operations, Biostatisticians, and Quality and Regulatory teams to execute study plans.

• Draft design verification and validation study documentation, including study protocols and reports, for review.

• Contribute to FDA PMA submission packages under the guidance of your manager.

• Prepare data summaries for Formal Design Reviews and key program milestones.

• Contribute to Delfi's design control process throughout the product life cycle, including plans, risk assessments, and design verification activities, to advance the assay toward product requirements and milestones.

• Support Delfi's culture of compliance by following and contributing to scalable tools, structures, and processes for compliant product development.

• Provide technical guidance and mentorship to associate scientists and research associates on validated methods and best practices.

What you’ll bring to DELFI

Required

• Doctoral degree in Molecular Biology or a related field; or Master's degree with 2+ years of relevant work experience; or Bachelor's degree with 5+ years of relevant work experience; or equivalent.

• 2+ years of experience developing molecular or genomic assays.

• Hands-on NGS assay development experience, ideally with liquid biopsies (genomic and/or multiomics).

• Experience with design of experiments (DOE), assay optimization, and data-driven decision making.

• Working knowledge of developing products within a Design Control / regulated environment (FDA 21 CFR Part 820, ISO 14971, ISO 13485, IVDR).

• Strong analytical skills with the ability to independently solve complex technical problems and adapt established approaches to new situations.

• Proven ability to collaborate cross-functionally and communicate effectively with technical and non-technical stakeholders.

Preferred

• Experience with multiomics assays and the integration of multiple omics under one product.

• Experience with cfDNA or fragmentomics-based assays.

• Exposure to design verification and/or PMA submissions.

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.