Research Scientist jobs in United States

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.

• 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.

• 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.