R&D Executive - Biochemistry

Key Responsibilities

1. Immunoassay Development: Support development, optimization, and validation of immunoassay-based diagnostic products using CLIA, FIA, and ELISA technologies.
2. Assay Optimization: Perform optimization of assay parameters including antibody/antigen concentration, conjugates, buffers, incubation conditions, blocking agents, and reaction conditions.
3. Reagent Development: Handle preparation, optimization, and performance evaluation of immunoassay reagents, calibrators, controls, and related components.
4. Laboratory Experiments: Execute laboratory experiments and maintain accurate records of test results, observations, calculations, and experimental protocols.
5. Analytical Performance: Conduct analytical studies such as precision, sensitivity, specificity, linearity, LoD/LoQ, interference, cross-reactivity, stability, and reproducibility .
6. Instrument & Platform Testing: Work with relevant CLIA, FIA, and ELISA instruments/platforms and support assay integration, troubleshooting, and performance evaluation.
7. Troubleshooting: Investigate assay failures, inconsistent results, background issues, signal-to-noise variations, and other technical challenges through structured root-cause analysis.
8. Documentation: Prepare and maintain SOPs, test protocols, development reports, validation reports, batch records, and other technical documentation in accordance with QMS and regulatory requirements.
9. Cross-Functional Coordination: Coordinate with Quality, Production, Regulatory, Clinical, and Application/Technical teams for product development, transfer, validation, and commercialization activities.
10. Literature & Technology Evaluation: Stay updated on emerging immunoassay technologies, antibodies, recombinant proteins, conjugation techniques, detection systems, and relevant IVD developments to support new product initiatives.