• Designed and executed verification & validation (V&V) protocols and reports of existing rapid diagnostics products (Influenza A&B, Leptospira IgM, HIV/Syphilis etc.) in need of raw material change• Monitored and supported risk management activities (FMEA) based on international guidelines (CLSI, IVD, FDA)• Recognize adverse trends and perform RCA of customer complaints. Propose and implement scientific solutions to issues.

• Drafted and performed feasibility tests to improve sensitivity and specificity of lateral flow assay devices• Managed 3000+ pathogenic samples - Influenza, COVID-19, Malaria, Dengue to ensure qualitative analysis of antigen-antibody detection. Screening via antibody optimization based on stability comparison and binding affinity • Presented data findings using analytical instrumentation (e.g., SDS-PAGE and HPLC) and biological assays (e.g., ELISA and DTNB assay) to optimize antibody containing gold-nanoparticles• Collaborated with the Reagent Development, QA/QC and Global teams to execute verification and validation studies requiring bioanalytical clinical studies• Transferred and revised standard test methods and developed processes for change in materials