Senior Research Associate (Assay Development and Manufacturing Associate) - Contract
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The Role
The Sr. Research Associate will perform quality control testing for GMP-grade reagents, support assay development, and maintain documentation in a regulated laboratory environment.
Summary Generated by Built In
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.
About the Role
Join our innovative team dedicated to reducing cancer deaths through cutting-edge liquid biopsy diagnostics. As Sr. Research Associate, you will be responsible for performing functional quality control testing of incoming GMP-grade reagents, preparing manufacturing controls, and supporting our CLIA-certified laboratory operations. You will work with molecular and biochemical assays, utilizing automated liquid handling systems to ensure our manufacturing processes meet stringent quality standards. Additionally, you will support research and development activities as needed, contributing to method optimization and validation studies.
This contract position requires strong attention to detail and the ability to work in a regulated GMP/CLIA environment where precision and documentation are critical.
What you'll do
- Manufacturing & Quality Control
- Perform functional and other quality control testing on incoming reagents for molecular and biochemical assays with meticulous attention to detail and adherence to high-quality standards.
- Execute reagent qualification protocols following established SOPs and manufacturing procedures
- Prepare manufacturing controls and reference standards
- Operate automated liquid handling systems (Hamilton or similar platforms) for high-throughput reagent testing
- Maintain comprehensive documentation in compliance with FDA 21 CFR 820, GMP requirements, and CLIA regulations
- Track reagent lot numbers, expiration dates, and qualification results in inventory management systems
- Design, execute, and troubleshoot moderate to complex laboratory experiments utilizing molecular biology techniques for Next-Generation Sequencing (NGS).
- Assist with method optimization and validation studies for assay and QC method development
- Perform guard banding, stability and other studies, and analytical characterization experiments
- Execute experimental workflows to support product development activities
- Contribute to troubleshooting and resolving technical challenges in assay performance
- Communicate effectively with Quality Assurance, Manufacturing, and R&D teams regarding reagent performance and study results
- Participate in manufacturing operations while maintaining strict environmental controls for laboratory work
- Support multidisciplinary project teams as needed
Research & Development Support:
Cross-Functional Collaboration:
What You'll Have Accomplished 6 Months From Now
- Become proficient in executing all reagent qualification protocols for multiple assay types
- Successfully qualified multiple reagent lots using automated liquid handlers with consistent, high-quality results
- Supported manufacturing laboratory infrastructure setup and process establishment, including development of equipment maintenance schedules and calibration plans
- Developed GMP-compliant documentation including SOPs, work instructions, and quality control policies for manufacturing operations
What you'll bring to DELFI
- Required qualifications:
- BS with 3-4 years of experience, or MS with 2-3 years in relevant field (e.g., biomedical engineering, molecular biology, genetics, or genomics)
- Hands-on experience with automated liquid handling systems (Hamilton, Tecan, or similar platforms)
- Direct experience in a regulated environment (CLIA, CAP, FDA, GXP, etc.)
- Proficiency in high-throughput manual and automated laboratory techniques for molecular biology and biochemical assays
- Strong analytical skills with ability to independently design experiments, troubleshoot technical challenges, and interpret results using sound scientific reasoning
- Excellent technical writing capabilities for developing protocols, SOPs, and development reports
- Superior organizational and project management skills with meticulous documentation practices, strategic planning abilities, and keen attention to detail
- Demonstrated ability to work independently while communicating effectively with cross-functional teams
- Direct experience working in a CLIA-certified laboratory or GMP manufacturing environment and familiarity with FDA 21 CFR 820 and ISO 13485 quality system requirements
- Experience with method development, optimization, and validation studies with NGS assays
- Experience with inventory management and lot tracking systems (NetSuite or similar ERP systems)
- Understanding of contamination control requirements for laboratory environments
- Data analysis skills using Excel or statistical software packages
Preferred qualifications:
An equal opportunity employerWe 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.
Top Skills
Automated Liquid Handling Systems
Biochemical Assays
Inventory Management Systems
Molecular Biology
Next-Generation Sequencing
Statistical Software
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The Company
What We Do
DELFI uses artificial intelligence and whole genome sequencing to sensitively detect unique patterns of DNA fragmentation in the blood of patients with cancer.
