Senior Research Associate, Assay Development (Contract)

DELFI Diagnostics, Inc.; Palo Alto (CA); On-site; USD 72,000 - 87,000; Full time

Job summary

DELFI Diagnostics, Inc. is seeking a Sr. Research Associate to develop and validate next-generation sequencing assays from concept through commercial launch.

You will collaborate with scientists, engineers, and bioinformaticians in a GLP/CAP/CLIA/FDA-regulated environment to ensure quality and regulatory compliance. You will contribute to product development, verification and validation activities for NGS-based tests for early cancer detection, with emphasis on meticulous documentation,

Qualifications

• BS with 3-4 years of experience or MS with 2-3 years relevant field (e.g., biomedical engineering, molecular biology, genetics, or genomics) in assay development for the life science industry
• Ability to work PM shift 4PM to 12AM for up to 3 months during January - March
• Proven ability to troubleshoot, communicate and elevate while working with limited support on a PM shift
• Proficient in high-throughput manual laboratory techniques, including precision pipetting for large-scale sample processing
• Proven track record in laboratory NGS execution and addressing technical challenges in nucleic acid extraction and library preparation for NGS
• Strong analytical skills with demonstrated ability to independently
• Superior organizational and project management abilities with meticulous documentation and time management

Responsibilities

• Design, execute, and troubleshoot moderate to complex laboratory experiments utilizing molecular biology techniques for Next-Generation Sequencing (NGS)
• Perform end-to-end experimental workflows, including nucleic acid extraction, library preparation, and sequencing, with meticulous attention to detail
• Communicate findings effectively with multidisciplinary teams and present at scientific meetings
• Contribute to advancing assays through design control processes to meet product requirements and regulatory standards by maintaining documentation

Skills

NGS experience

Molecular biology

High-throughput pipetting

Analytical skills

Project management

Education

BS with 3-4 years experience or MS with 2-3 years in relevant field

Tools

Automated liquid handling systems

Python/R programming

Job description

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.

What You’ll Do

As Sr. Research Associate, you will play a critical role in developing and validating next-generation sequencing assays from concept through commercial launch, working within a collaborative environment of scientists, engineers, and bioinformaticians. You will contribute to product development, verification and validation activities for NGS-based laboratory tests for early cancer detection. The ideal candidates would have experience working under Good Laboratory Practice (GLP) in a CAP/CLIA/FDA-regulated environment.

Contribute to the success of a cohesive, innovative, motivated team that is dedicated to reducing cancer deaths through the following activities:

• Design, execute, and troubleshoot moderate to complex laboratory experiments utilizing molecular biology techniques for Next-Generation Sequencing (NGS).

• Perform end-to-end experimental workflows, including nucleic acid extraction, library preparation, and sequencing, while preparing samples and executing experiments with meticulous attention to detail and adherence to high-quality standards.

• Communicate findings effectively with multidisciplinary teams, including biologists, bioinformaticians, statisticians, automation engineers, and quality control scientists, and present at scientific meetings.

• Contribute to advancing assays through design control processes to meet product requirements and regulatory standards by maintaining comprehensive documentation.

What You’ll Bring

Required:

• BS with 3-4 years of experience, or MS with 2-3 years relevant field (e.g., biomedical engineering, molecular biology, genetics, or genomics) in assay development for the life science industry

• Ability to work PM shift 4PM to 12AM for up to 3 months during January - March

• Proven ability to thoughtfully troubleshoot, communicate and elevate while working with limited support on a PM shift

• Proficient in high-throughput manual laboratory techniques, including precision pipetting for large-scale sample processing

• Proven track record in laboratory NGS execution and addressing technical challenges specific to nucleic acid extraction and library preparation for NGS.

• Strong analytical skills with demonstrated ability to independently

• Superior organizational and project management abilities, including meticulous documentation practices, strategic planning, and effective time management with keen attention to detail

Preferred:

• Hands-on experience with automated liquid handling systems for assay development and execution

• Experience troubleshooting and communicating issues

• Advanced data analysis skills using Excel and statistical software packages; programming experience in Python, R or similar languages is highly valued

• Direct experience in a regulated environment (CLIA, CAP, NYS, FDA, GXP, etc.)

$52 - $63 an hour

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.