Key Responsibilities:
    •    Design, develop, and optimize hCG immunoassays for IVD applications (e.g., lateral flow, ELISA, chemiluminescence).
    •    Develop and validate reagents, antibodies, and buffers for consistent assay performance.
    •    Optimize assay sensitivity, specificity, and stability for commercial use.
    •    Troubleshoot and resolve assay performance issues through experimental design.
    •    Conduct feasibility studies, prototype testing, and data analysis for assay performance.
    •    Collaborate with cross-functional teams (manufacturing, quality, regulatory affairs).
    •    Ensure compliance with IVD regulatory requirements (ISO 13485, FDA, CE-IVD).
    •    Document experimental procedures, protocols, and results for regulatory submissions.
    •    Support technology transfer to manufacturing and scale-up processes.

Required Qualifications:
    •    PhD/Master’s/Bachelor’s in Biochemistry, Molecular Biology, Analytical Chemistry, Biomedical Engineering, or related field.
    •    2+ years experience in IVD assay development (preferably in immunoassays like ELISA, lateral flow, or chemiluminescence).
    •    Strong expertise in protein chemistry, antibody-based assays, and reagent formulation.
    •    Hands-on experience with assay validation, troubleshooting, and quality control.
    •    Knowledge of regulatory and quality standards (ISO 13485, FDA 21 CFR Part 820).
    •    Strong analytical and problem-solving skills, with attention to detail.
    •    Ability to work in a fast-paced, collaborative environment.