Delfidiagnostics

Principal Scientist, IVD Reagent Development and Manufacturing

Palo Alto, CA · Principal

Sponsorship not specified$180k-$230kDetected 21 days ago

Data AnalysisAuditingFDA RegulatoryMolecular BiologyNGSCommunicationMentoringGxP

About the role

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.
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.
Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists.
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.
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.

Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.
Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones.
Experience with IVD reagent kitting and reagent interchangeability

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.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

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.

This listing is sourced directly from Delfidiagnostics's careers page and normalized into a canonical job model.