Overview
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.
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
- 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.