Sr. Scientist- Molecular Diagnostics and Infectious Disease

StrainX Biotech; Bengaluru; On-site; INR 1,080,000 - 1,320,000; Full time

Job summary

Biopatrika is hiring a Sr. Scientist- Molecular Diagnostics and Infectious Disease in Bangalore. The role requires a PhD in Biotechnology, Microbiology or related field, with 2+ years of experience handling highly infectious disease samples and strong hands-on molecular biology skills.

You will lead the development and QA of molecular IVDs while ensuring regulatory compliance and robust documentation in line with ISO 13485 and MDR 2017.

Qualifications

• PhD in Biotechnology, Microbiology or related field.
• 2+ years' experience handling infectious disease samples.
• Experience with ISO 13485 and MDR 2017 lab documentation and records.

Responsibilities

• Lead design, development, QC/QA of molecular IVDs and clinical evaluation.
• Ensure regulatory compliance with CDSCO, ICMR; manage documentation and equipment maintenance.

Skills

Infectious samples handling

DNA/RNA isolation

RT-PCR

Molecular biology

Regulatory docs

Vendor coordination

IVD QA/QC

Regulatory knowledge

Primer/probe design

Analytical validation

Clinical evaluation

Education

PhD in Biotechnology/Microbiology

Job description

We’re Hiring | Sr. Scientist- Molecular Diagnostics and Infectious Disease

Location: Bangalore

We are looking for a qualified experienced PhD Biotechnology, Microbiology or related professional to join an upcoming Molecular Diagnostics team. Please note : Only Valid IVD company experience will be considered no reasearch institute exp. CTC : Upto 12LPA

Key Requirements :

• Minimum 2+ years’ experience handling, processing, testing ; reporting highly infectious disease samples — TB, HIV, HBV, HCV, Syphilis, Malaria, etc.
• Strong hands‑on experience in DNA/RNA isolation, RT-PCR, SDS-PAGE, cloning and molecular biology techniques.
• Experience in ISO 13485; MDR 2017 lab documentation, records and equipment maintenance.
• Vendor coordination and supply-chain management for uninterrupted laboratory operations.
• Experience in design, development, QC amp; QA of molecular IVDs.
• Knowledge of CDSCO, ICMR ; DBT technical/regulatory requirements.
• Bioinformatics experience in identifying pathogen‑specific/conserved genomic or transcriptomic regions while minimizing cross‑reactivity.
• Experience with primer/probe design, enzyme/master‑mix optimization, stability, shelf‑life amp; lyophilization.
• Knowledge of analytical validation: LoD, specificity, cross‑reactivity, interference; precision, aligned with CLSI/WHO/CDSCO-ICMR guidelines.
• Experience in clinical evaluation using blood, swab, plasma or other clinical specimens.
• Strong experience in molecular diagnostics, regulatory compliance and laboratory leadership Experience in managing QA/QC, ISO 13485, MDR 2017 and regulatory requirements.

If you are passionate about infectious disease diagnostics, molecular biology and IVD product development, we would love to hear from you!