Nnamdi Okeke

WORK HISTORY

EDUCATION

ABOUT NNAMDI OKEKE

Results-driven and innovative scientist with experience developing high-throughput, quantitative multiplex immunofluorescence assays for oncology and precision medicine. Managed end-to-end assay development—from biomarker discovery and optimization through validation, regulatory submission, and commercialization. Committed to advancing precision medicine through innovation, collaboration, and quality execution.• Biomarker Assay Development: Extensive hands-on experience designing, optimizing, and validating monoplex and multiplex assays for oncology CDx in regulated environments.• Immunoassay & Molecular Techniques: Skilled in ELISA based technique and Flow Cytometry to support biomarker validation, assay feasibility, and molecular characterization.• Tissue Processing & Cell Culture: Proficient in FFPE tissue handling, sectioning, and staining, as well as maintaining cell lines for assay development and pre-analytical variable studies.• Image Analysis & Digital Pathology: Skilled in applying AI-based image analysis tools (e.g, HALO) for quantitative biomarker evaluation, enhancing reproducibility and enabling objective data reporting.• Regulatory Documentation: Authored validation protocols, design control documents, and scientific validity reports for FDA 510(k) and IVDR submissions; maintained audit-ready DHFs.• Process Optimization: Led workflow improvements that reduced development timelines and reagent waste, improving efficiency and cross-lab assay reproducibility.• Cross-Functional Collaboration: Effectively partnered with QA, Regulatory, R&D, and pharma clients to align on design inputs, risk management, and product development milestones.