Molecular Biologist – Product Development (RT-PCR Diagnostics)
BioTalent Search® · Pune District, Maharashtra, India
Apply & track with Apply EdgeMolecular Biologist – Product Development (RT-PCR Diagnostics)Hiring for our well-known client in the Molecular Diagnostics industry
The candidate will join their R&D team and contribute to the design, development, optimization, and validation of molecular diagnostic assays and nucleic acid extraction chemistries for RT-PCR-based IVD products.Candidates with experience in Molecular Diagnostics, IVD, RT-PCR assay development, or diagnostic product development will be preferred.Key Responsibilities1. Molecular Diagnostic Kit DevelopmentDesign and develop RT-PCR-based IVD assays for infectious diseases and genetic applications.Conduct literature reviews, target selection, primer/probe design, and assay optimization.2. Nucleic Acid Extraction ChemistryDevelop and optimize DNA/RNA extraction chemistries for different clinical sample types.Evaluate extraction efficiency, inhibitor removal, and compatibility with RT-PCR assays.3. Assay Optimization & ValidationOptimize PCR chemistry, reaction conditions, and multiplex assay performance.Conduct analytical validation studies including LoD, LoQ, linearity, precision, specificity, inclusivity, exclusivity, robustness, and stability.4. Product DevelopmentDrive assigned product development projects from concept through validation and commercialization.Support product improvement and lifecycle management activities.5. Experimental WorkPerform RT-PCR, qPCR, nucleic acid extraction, and other molecular biology techniques.Analyze experimental data and troubleshoot assay performance issues.6. Quality & Regulatory CompliancePrepare SOPs, protocols, validation reports, technical documentation, and design history files.Ensure compliance with ISO 13485, GLP, GMP, and applicable regulatory requirements.7. Product Performance & CAPASupport investigation of product complaints, assay deviations, and field performance issues.Participate in root cause analysis and CAPA implementation.8. Laboratory ManagementMaintain laboratory infrastructure, equipment qualification, environmental monitoring, cleaning records, and inventory.Ensure compliance with laboratory safety and quality practices.9. Scientific DocumentationMaintain accurate experimental records and prepare technical reports, presentations, and project documentation.Contribute to technical dossiers, grant proposals, publications, and scientific collaborations.10. Cross-functional CollaborationWork closely with Quality Assurance, Manufacturing, Regulatory Affairs, Clinical Affairs, and Project Management teams.Support other R&D activities as assigned by the reporting manager.Desired SkillsStrong knowledge of Molecular Biology, PCR, RT-PCR, and qPCR.Hands-on experience in primer/probe design and multiplex PCR assay development.Experience in nucleic acid extraction chemistry development and optimization.Knowledge of analytical and clinical validation of IVD assays.Familiarity with bioinformatics tools for oligonucleotide design.Experience with lyophilized PCR reagents will be an added advantage.Knowledge of ISO 13485, IVDR/IVD regulations, and design control documentation.Strong analytical, troubleshooting, documentation, and communication skills.Preferred Experience3–5 years of industrial experience in Molecular Diagnostics, Biotechnology, or IVD product development.Experience developing RT-PCR-based diagnostic kits from concept through validation and transfer to manufacturing.Experience in assay design, multiplex PCR, extraction chemistry, and analytical validation will be preferred.Why Join?This role offers an opportunity to work with a well-established organization in the Molecular Diagnostics industry and contribute to the development of innovative molecular diagnostic products and advanced RT-PCR technologies in a collaborative R&D environment.