IVD Assay Characterization & Validation Consultant

IVD Assay Characterization & Validation ConsultantHybrid – Indianapolis, IN (3 days onsite / 2 remote)Seeking a hands‑on scientist to drive assay characterization, validation, and regulatory documentation for automated clinical chemistry assays. This role focuses on translating complex biochemical methods into scalable, manufacturable IVD products.What You’ll DoLead CLSI‑aligned assay characterization and validation protocol developmentDesign studies for precision, linearity, interferents, stability, LoD/LoQ, and AMROperate and troubleshoot automated chemistry analyzers (Cobas experience preferred)Execute multi‑day protocols (e.g., EP05), spike‑and‑recovery, and dilution workflowsConduct method comparison studies and resolve complex matrix behavior issuesAnalyze datasets using validation software; build statistical models and bias metricsAuthor MVRs, DHF documentation, and FDA Q‑Sub technical packagesSupport regulatory strategy and frame technical questions for FDA interactionsMentor lab staff on SOPs, protocols, and analytical best practicesWhat You BringBS/MS/PhD in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related field2+ years in IVD assay development/validation in FDA/ISO‑regulated environmentsStrong CLSI fluency and hands‑on experience with automated analyzersFamiliarity with FDA 510(k) matrix expansion and Q‑Sub processesExceptional experimental rigor, analytical problem‑solving, and data integrityAbility to communicate complex findings across scientific, engineering, and regulatory teamsSelf‑directed, detail‑driven, and comfortable in fast‑paced development settingsAbout the OrganizationFocused on advancing near‑patient diagnostic solutions that support diabetes management and continuous monitoring. The Indianapolis site manufactures high‑volume blood glucose monitoring products and is expanding into sensor manufacturing for next‑generation continuous glucose monitoring systems.