To Whom It May Concern,
I am a seasoned life sciences professional with a PhD in Bioinformatics and Structural Biology from the Free University of Brussels (2004) and over eighteen years of hands-on experience in the development, validation and production of in vitro diagnostic assays. Throughout my career, I have applied rigorous scientific and regulatory standards to bring high-performance immunoassays to market, first in human diagnostics and more recently in food-safety testing.
From 2004 to 2016 at Immunodiagnostic Systems (Liège, Belgium), I advanced from R&D Scientist to Project Leader, overseeing the full lifecycle of luminescent immuno-assays (LIA, ILMA, ELISA, RIA, IRMA). I orchestrated experimental planning, protocol design, data analysis, report writing and regulatory submissions for both CE-mark and U.S. markets. My role required close collaboration with quality, manufacturing and supply-chain teams, as well as vendor negotiation for critical raw materials.
In 2016 I joined UNISENSOR as Production Development Team Leader and later Technical Excellence Team Leader. I led cross-functional teams in the development, control and manufacture of rapid immunochromatographic tests for feed and food diagnostics. I was charged with ensuring compliance with 21 CFR and NCCLS guidelines, establishing robust statistical frameworks (DOE, hypothesis testing) for QC and production, and authoring transfer protocols, validation plans and submission dossiers.
Since January 2025, I have served as an independent consultant, partnering with companies such as Arbor Assays in Michigan, to support R&D projects in ELISA, lateral-flow, and immunochromatographic assay development. My technical expertise spans:
• Protein purification by HPLC (RP-HPLC, IEX) and structural analysis
• Monoclonal antibody engineering and characterization (Octet K2)
• Stability studies using Arrhenius/Q10 modeling
• Analytical method validation and regulatory submission
• Statistical design of experiments and QC optimization
• Troubleshooting of biochemical formulations
My commitment to scientific rigor, combined with proven leadership in technical excellence and regulatory compliance, positions me to deliver reliable, market-ready diagnostic solutions. I welcome the opportunity to discuss how my expertise can advance your assay development objectives.