The Role
Department: R&D / Manufacturing Reports to: Head – R&D / Technical Director Role Summary The Research Scientist will be responsible for research, development, optimization, validation, and transfer to manufacturing of RT-PCR diagnostic kits. The role involves assay design, troubleshooting, analytical validation, and ensuring compliance with regulatory and quality standards for molecular diagnostics. Key Responsibilities • Assay Development & Optimization • Design and optimize primers, probes, and reaction conditions for real-time PCR–based assays. • Develop multiplex RT-PCR assays with high sensitivity and specificity. • Standardize sample preparation, nucleic acid extraction, and amplification workflows. • Validation & Verification • Conduct analytical validation (LOD, linearity, specificity, cross-reactivity, precision, reproducibility). • Support clinical validation studies with reference materials and clinical samples. • Prepare technical reports and validation documents. • Technology Transfer & Manufacturing • Scale-up optimized assays for routine kit manufacturing. • Prepare and standardize master mixes, controls, and QC panels. • Work closely with production and QA/QC teams for batch release and troubleshooting. • Regulatory & Quality Compliance • Ensure compliance with ISO 13485, IVD regulations, and applicable international standards. • Draft and maintain SOPs, technical files, and risk management documents. • Support regulatory submissions and audits. • Cross-Functional Collaboration • Liaise with product management, manufacturing, and quality teams to ensure smooth R&D-to-market transition. • Train technical staff on new assay protocols and troubleshooting.
Requirements
Qualifications • Ph.D. / M.Sc. / M.Tech. in Molecular Biology, Biotechnology, Biochemistry, Microbiology Life Sciences, Genetics or related field. Experience in NGS/Genomics would be a plus. Experience in assay design, troubleshooting, analytical validation, and ensuring compliance with regulatory and quality standards for molecular diagnostics.
About the company
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Please refer the Job description for details