Delfi Diagnostics is hiring a Principal Scientist, IVD Reagent Development and Manufacturing
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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.
Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents that will be used for DELFI’s molecular diagnostic assays.
Lead the Reagent Development and Operations team and be accountable for Process Validation and Design Transfer from R&D to Operations.
Define reagent criticality (Key, Ancillary, General Use) for DELFI's IVD molecular diagnostic assays, and develop reagent FMEA to inform testing rigor and change control requirements.
Develop and qualify QC test methods for reagent lot release, including method design, acceptance criteria, lot release procedures, and integration with batch manufacturing records.
Evaluate Contract Reagent Manufacturers. Be the primary point of contact and be accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements. Participate in Quality audits.
Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.
Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists.
Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones.
Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents that will be used for DELFI’s molecular diagnostic assays.
Lead the Reagent Development and Operations team and be accountable for Process Validation and Design Transfer from R&D to Operations.
Define reagent criticality (Key, Ancillary, General Use) for DELFI's IVD molecular diagnostic assays, and develop reagent FMEA to inform testing rigor and change control requirements.
Develop and qualify QC test methods for reagent lot release, including method design, acceptance criteria, lot release procedures, and integration with batch manufacturing records.
Evaluate Contract Reagent Manufacturers. Be the primary point of contact and be accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements. Participate in Quality audits.
Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.
Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists.
Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones.
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Salary: $180000-260000
🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.
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