Molecular Biologist Product Development (RT-PCR Diagnostics)

Molecular Biologist – Product Development (RT-PCR Diagnostics)

Hiring for our well-known client in the Molecular Diagnostics industry

Location: Pune District, Maharashtra

Department: Research & Development (R&D)

Position: Associate Scientist

Experience: 3–5 Years

Qualification: M.Sc. / M.Tech. / Ph.D. in Biotechnology, Molecular Biology, or related field

About the Role

We are looking for a Molecular Biologist 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 Responsibilities

1. Molecular Diagnostic Kit Development

• Design 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 Chemistry

• Develop 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 & Validation

• Optimize 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 Development

• Drive assigned product development projects from concept through validation and commercialization.
• Support product improvement and lifecycle management activities.

5. Experimental Work

• Perform RT-PCR, qPCR, nucleic acid extraction, and other molecular biology techniques.
• Analyze experimental data and troubleshoot assay performance issues.

6. Quality & Regulatory Compliance

• Prepare SOPs, protocols, validation reports, technical documentation, and design history files.
• Ensure compliance with ISO 13485, GLP, GMP, and applicable regulatory requirements.

7. Product Performance & CAPA

• Support investigation of product complaints, assay deviations, and field performance issues.
• Participate in root cause analysis and CAPA implementation.

8. Laboratory Management

• Maintain laboratory infrastructure, equipment qualification, environmental monitoring, cleaning records, and inventory.
• Ensure compliance with laboratory safety and quality practices.

9. Scientific Documentation

• Maintain accurate experimental records and prepare technical reports, presentations, and project documentation.
• Contribute to technical dossiers, grant proposals, publications, and scientific collaborations.

10. Cross-functional Collaboration

• Work 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 Skills

• Strong 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 Experience

• 3–5 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.