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; workplace.

📌 Molecular Biologist Product Development (RT-PCR Diagnostics) (Pune)
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