Staff Scientist, Assay Development

DELFI Diagnostics; Palo Alto (CA); On-site; USD 125,000 - 175,000; Full time

Job summary

A leading healthcare diagnostics company in Palo Alto seeks a Senior or Staff Development Scientist. You will lead the development of multiomics molecular diagnostic assays for lung cancer screening. Candidates should have significant experience in Next-Generation Sequencing and assay development. This full-time position requires on-site work with some hybrid flexibility, offering a competitive salary within $125,000 to $175,000 per year.

Qualifications

• 5+ years of industry assay development experience in relevant disciplines.
• Hands-on experience with reagent development and assay optimization in a regulated lab setting.
• Experience in writing protocols and analyzing results.

Responsibilities

• Design and optimize assay and quality control parameters.
• Develop processes for reagent manufacturing and quality control.
• Document development requirements and ensure compliance.

Skills

Next-Generation Sequencing (NGS)

Cross-functional team collaboration

Reagent development

Assay optimization

Education

PhD or Master's in Molecular Biology, Biochemistry, Chemistry

Tools

R

Python

JMP

Automated liquid handlers

Job description

Overview

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 lead the development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications. The ideal candidate has a strong scientific foundation in Next-Generation Sequencing (NGS) with liquid biopsies for genomic and proteomic analyses, technical leadership experience, 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 and is onsite 5 days a week when laboratory work requires it.

About DELFI Diagnostics

DELFI Diagnostics, Inc. is developing next-generation, blood-based tests to detect cancer. The DELFI platform uses fragmentomics and machine-learning methods on whole-genome sequencing data to address high-burden health challenges and serve diverse populations. FirstLook Lung is the company’s lung cancer screening test, designed to be part of routine blood work. This test has not been cleared or approved by the FDA.

Responsibilities

• 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 experiments, 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 you’ll accomplish 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 you’ll bring to DELFI

• Required
• PhD with 5+ years or Master’s with 8+ years of industry assay development 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 experience with reagent development and assay optimization in an IVD or LDT product development context within a regulated laboratory environment (GLP)
• Experience in writing protocols, designing experiments, analyzing results, and documenting outcomes in reports
• Clear communication skills, ability to work with cross-functional teams, and experience mentoring and training junior scientists and other stakeholders, fostering a collaborative, data-driven culture
• Ability to work on-site at our Palo Alto laboratory five days a week when required 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 R, Python, or JMP
• Developing or executing assays using automated liquid handlers is preferred
• Product transfer in a regulated and ISO-compliant environment

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.

Compensation

Base pay range: $125,000.00/yr - $175,000.00/yr

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.

Details

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.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Biotechnology Research, Technology, Information and Internet, and Software Development