Qureos Mentor

TheSay

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
 <ul>
<li>Ph.D. / M.Sc. / M.Tech. in Molecular Biology, Biotechnology, Biochemistry, Microbiology Life Sciences, Genetics or related field. • PhExperience in NGS/Genomics would be a plus. • PhExperience in assay design, troubleshooting, analytical validation, and ensuring compliance with regulatory and quality standards for molecular diagnostics.</li>
</ul>
About the company
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Research Scientist (RT-PCR Kit R&D and Manufacturing)

Join TheSay and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

TheSay

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Research Scientist (RT-PCR Kit R&D and Manufacturing)