Principal Scientist, IVD Reagent Development and Manufacturing
Job Location:
Palo Alto, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 DELFIs 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 DELFIs 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 DELFIs 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 DELFIs 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.
Required
PhD with 8 years or Masters with 10 years industry assay/reagent development with experience in Molecular Biology Biochemistry Chemistry or a similar discipline
3 years of developing IVD diagnostic tests with NGS cfDNA/multi-omic assay technologies from plasma (e.g. DNA fragments RNA small variants methylation or immunoassays) under 21 CFR Part 820 or ISO 13485.
2 years of experience developing reagent specifications (format fill volume tolerance closure label shelf and in-use stability) reagent integrations with automated platforms and transferring reagent manufacturing from R&D to an internal department or an external contract reagent manufacturer.
Hands-on with reagent development for IVD or LDT product development experience working in a regulated laboratory environment (GxP).
Experience in writing protocols designing experiments analyzing and documenting results in reports.
Clear communication skills ability to work with team members in the same and adjacent disciplines and experience mentoring and training junior scientists and other cross-functional stakeholders to foster a collaborative knowledge-sharing and data-driven culture.
Ability to work on-site at our Palo Alto laboratory three to five days a week when required with periodic travel to the reagent manufacturer sites for audit purposes.
Preferred
Experience with IVD reagent kitting and reagent interchangeability
Experience in developing reagent QC methods and Process Validation for reagent manufacturing.
Experience in managing R&D relationships and auditing reagent suppliers.
Required Experience:
Staff IC
