Job Title: Scientist – Reagent Department: Research & Development – Diagnostics

Location:
Vapi, Gujarat Reports To: R&D; Manager – Diagnostics

Experience:
2–6 Years Job Purpose To research, develop, formulate, optimize, characterize, and validate diagnostic reagents for automated In-Vitro Diagnostic (IVD) systems, particularly Clinical Chemistry and Immunoassay Analyzers. The role involves developing biochemical and immunochemical reagent formulations, optimizing diagnostic assay methodologies, evaluating raw material properties, conducting analytical performance studies, and establishing reagent stability and shelf-life. The scientist will work closely with instrument engineering, biochemistry, analytical chemistry, application, quality, and manufacturing teams to develop reliable, high-performance, reproducible, and commercially scalable diagnostic reagents.

Key Responsibilities
1. IVD Reagent Research & Formulation Development
• Research, develop, and optimize reagent formulations for clinical chemistry and immunodiagnostic applications.
• Develop biochemical and enzymatic reagent systems involving enzymes, substrates, buffers, stabilizers, surfactants, preservatives, and other functional ingredients.
• Perform formulation experiments, concentration optimization, and component compatibility studies.
• Evaluate chemical and biochemical properties of raw materials used in diagnostic reagent development.
• Study the effect of pH, ionic strength, buffer capacity, temperature, and reagent composition on assay performance.
• Develop formulations with consistent analytical performance, reproducibility, and long-term stability.
• Maintain detailed experimental records, formulation histories, and laboratory observations. 2. Clinical Chemistry Assay Development
• Develop and optimize enzymatic, colorimetric, endpoint, kinetic, and turbidimetric assay methodologies.
• Work on clinical chemistry parameters including:
• Glucose – GOD-POD / GOD-PAP methodologies.
• Cholesterol – CHOD-PAP methodology.
• Triglycerides – GPO-PAP methodology.
• Urea – Urease-based methodology.
• Creatinine – Jaffe and enzymatic methodologies.
• Uric Acid – Uricase-based methodology.
• ALT / AST – Enzymatic methodologies.
• Total and Direct Bilirubin.
• Total Protein and Albumin.
• Optimize reaction kinetics, incubation time, temperature, pH, substrate concentration, and sample-to-reagent ratios.
• Evaluate reaction mechanisms and analytical signal generation.
• Investigate assay performance variations and identify opportunities for improvement. 3. Immunoassay & Immunodiagnostic Reagent Development
• Support development and optimization of immunochemical reagent systems for diagnostic applications.
• Work with antigen-antibody interactions, immunological binding mechanisms, and assay chemistry.
• Develop or optimize ELISA, immunoturbidimetric, CLIA, and FIA-based assay methodologies, depending on project requirements.
• Evaluate monoclonal and polyclonal antibodies, antigens, conjugates, blocking agents, and assay buffers.
• Study antibody affinity, specificity, cross-reactivity, and nonspecific binding.
• Optimize signal generation, signal-to-background ratio, and detection performance.
• Support development of immunodiagnostic assays for parameters such as TSH, T3, T4, CRP, Troponin, Ferritin, Vitamin D, and other clinical biomarkers. 4. Biochemical & Analytical Characterization
• Perform chemical, biochemical, and physicochemical characterization of reagent formulations.
• Evaluate critical formulation properties including:
• pH and buffer capacity.
• Conductivity and ionic strength.
• Enzyme activity and specific activity.
• Protein concentration and purity.
• Absorbance and optical background.
• Viscosity and formulation homogeneity.
• Solubility and precipitation behaviour.
• Chemical and biological compatibility.
• Conduct analytical experiments using spectrophotometric and biochemical measurement techniques.
• Analyze reaction kinetics, calibration curves, and assay response characteristics.
• Investigate formulation incompatibilities,



degradation, and unexpected analytical variations. 5. Analytical Performance Evaluation & Validation
• Evaluate analytical performance of developed reagents using appropriate IVD performance evaluation protocols.
• Conduct studies covering:
• Precision and reproducibility.
• Accuracy and method comparison.
• Analytical sensitivity and specificity.
• Limit of Blank (LoB).
• Limit of Detection (LoD).
• Limit of Quantitation (LoQ).
• Linearity and analytical measuring range.
• Recovery and dilution studies.
• Interference and cross-reactivity.
• Carryover and reagent blank assessment.
• Perform comparative studies against established commercial diagnostic reagents and reference methods.
• Analyze experimental data, interpret results, and prepare technical evaluation reports.
• Support assay optimization based on analytical performance findings. 6. Reagent Stability & Shelf-Life Studies
• Plan and execute real-time and accelerated reagent stability studies.
• Evaluate open-vial, on-board, and transportation stability.
• Study the effects of temperature, light exposure, storage conditions, and packaging on reagent performance.
• Monitor changes in pH, appearance, enzyme activity, absorbance, and analytical performance.
• Evaluate the effectiveness of stabilizers, preservatives, and protective formulation systems.
• Investigate degradation, precipitation, contamination, and loss of reagent activity.
• Generate stability data to establish product shelf-life and recommended storage conditions. 7. Raw Material Selection & Supplier Evaluation
• Identify and evaluate raw materials required for IVD reagent development.
• Work with enzymes, antibodies, antigens, proteins, substrates, buffers, salts, stabilizers, preservatives, and surfactants.
• Evaluate raw material specifications, purity, activity, quality, and batch-to-batch consistency.
• Conduct incoming material evaluation and compatibility studies.
• Coordinate with procurement and quality teams for supplier qualification and raw material specifications.
• Identify opportunities for indigenous sourcing and cost-effective formulation development. 8. Diagnostic Analyzer Integration & Application Testing
• Work closely with clinical chemistry and immunoassay instrument development teams.
• Evaluate reagent performance on automated diagnostic analyzer platforms.
• Optimize sample and reagent volumes, dispensing parameters, incubation time, mixing conditions, and reaction temperature.
• Evaluate reagent compatibility with probes, tubing, cuvettes, reaction vessels, and fluidic pathways.
• Support photometric and other applicable detection-system integration.
• Investigate reagent-related application issues, calibration variations, blank values, and measurement inconsistencies.
• Support integrated reagent-analyzer performance verification. 9. Manufacturing Scale-Up & Process Development
• Support transition of laboratory-developed formulations into pilot and commercial manufacturing.
• Develop formulation SOPs, batch manufacturing records, and in-process quality specifications.
• Evaluate batch-to-batch consistency and process reproducibility.
• Support filling, packaging, and storage-condition optimization.
• Establish critical process parameters and finished-reagent acceptance criteria.
• Coordinate with manufacturing and quality teams for technology transfer and process validation.
• Support troubleshooting of manufacturing-related formulation and performance issues. 10. Medical Device Quality & Regulatory Compliance
• Follow design control, laboratory documentation, and quality management practices applicable to IVD product development.
• Prepare experimental protocols, formulation records,



analytical reports, validation reports, and technical specifications.
• Support design verification, design validation, risk assessment, and product development documentation.
• Understand applicable standards and regulatory requirements, including:
• ISO 13485 – Quality Management System for Medical Devices.
• ISO 14971 – Risk Management for Medical Devices.
• ISO 23640 – Stability Evaluation of IVD Reagents.
• ISO 18113 – Information Supplied by the Manufacturer for IVD Medical Devices.
• ISO 20916 – Clinical Performance Studies Using Human Specimens.
• CLSI EP05 – Precision Evaluation.
• CLSI EP06 – Linearity Evaluation.
• CLSI EP07 – Interference Testing.
• CLSI EP17 – LoB, LoD and LoQ Evaluation.
• CLSI EP25 – Stability Evaluation.
• Maintain proper laboratory records, data integrity, traceability, and compliance with applicable GLP and QMS procedures. Required Technical Skills
• Strong understanding of biochemistry, analytical chemistry, biotechnology, and diagnostic assay principles.
• Hands-on experience in IVD reagent formulation and development.
• Knowledge of enzymatic and colorimetric assay methodologies.
• Understanding of enzyme kinetics, biochemical reactions, and substrate specificity.
• Knowledge of buffers, stabilizers, preservatives, surfactants, and formulation optimization.
• Understanding of pH, conductivity, ionic strength, solubility, and reagent compatibility.
• Experience in analytical characterization and assay performance evaluation.
• Knowledge of precision, accuracy, linearity, sensitivity, specificity, and interference studies.
• Understanding of real-time and accelerated stability studies.
• Ability to perform experimental design, data analysis, interpretation, and scientific troubleshooting.
• Positive technical documentation, laboratory practices, and scientific report-writing skills. Laboratory Equipment & Analytical Instrumentation
• UV-Visible Spectrophotometer.
• HPLC and analytical chromatography systems.
• Analytical Balance.
• pH Meter and Conductivity Meter.
• Micropipettes and Centrifuges.
• ELISA / Microplate Reader.
• Automated Clinical Chemistry Analyzer.
• Immunoassay Analyzer.
• Temperature-controlled stability chambers.
• Laboratory formulation and sample preparation equipment. Educational Qualification
• M.
Sc. / M.
Tech. in Biochemistry, Biotechnology, Analytical Chemistry, Chemistry, Microbiology, Molecular Biology, or related Life Science disciplines.
• Ph.
D. candidates with relevant diagnostic assay or reagent development experience may also apply.
• Candidates with hands-on laboratory research, formulation development, analytical characterization, or diagnostic assay development experience will be preferred. Preferred Exposure
• Clinical Chemistry Reagent Development.
• Enzymatic and Colorimetric Assay Development.
• Immunoassay / Immunochemistry Development.
• ELISA, CLIA, FIA and Immunoturbidimetric Assays.
• Enzyme and Protein Biochemistry.
• Antibody-Antigen Interaction and Conjugation.
• Automated Clinical Chemistry and Immunoassay Analyzers.
• Reagent Stability and Shelf-Life Validation.
• Calibrator and Quality Control Material Development.
• IVD Product Development and Commercial Manufacturing. Key Performance Indicators (KPIs)
• Successful development and optimization of diagnostic reagent formulations.
• Number of assays developed, optimized, and technically validated.
• Achievement of defined analytical performance specifications.
• Improvement in reagent stability and shelf-life.
• Reproducibility and consistency of reagent formulations across batches.
• Successful integration and performance of reagents on automated analyzer platforms.
• Reduction in reagent-related analytical variations and formulation failures.
• Successful completion of laboratory-to-pilot manufacturing technology transfer.
• Timely completion of R&D; experiments, validation protocols, and technical documentation.
• Compliance with applicable quality, design control, and regulatory requirements.

📌 Scientist - Reagent R&D (Vapi)
🏢 Meril
📍 Vapi