DELFI Diagnostics is developing next-generation, blood-based tests to help detect cancer by employing advanced machine-learning methods to whole-genome sequencing data. The DELFI platform is built to address the highest-burden health challenges and prioritize solutions that have the potential to save lives on a global scale.
Requirements
- 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
- 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
Responsibilities
- 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
- 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
Other
- 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.
- 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
- 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)
- 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.
