General Manager - R&D (Molecular Diagnostics)

Transasia Bio-Medicals Ltd.; Visakhapatnam; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Transasia Bio-Medicals Ltd. seeks a senior leader to head Molecular Assay Development. You will drive RT-PCR/qPCR and NGS assay programs, shape the R&D roadmap, evaluate new technologies, and guide automation strategies to improve diagnostics across diseases.

You will manage regulatory submissions, ensure ISO/IVDR/CLIA compliance, and mentor a diverse team of scientists, bioinformaticians, and technicians in Vizag.

Qualifications

• 13–15 years hands-on experience in molecular assay development spanning RT PCR, qPCR and NGS.
• Experience with regulatory standards (IVD, CE-IVD, US FDA, WHO) and QbD principles.
• Leadership of multidisciplinary R&D teams across molecular biology, bioinformatics and validation.
• Ability to scale and transfer validated methods into manufacturing.

Responsibilities

• Lead the molecular assay development department and provide scientific and operational direction.
• Define the R&D roadmap for molecular diagnostics aligned with company strategy.
• Evaluate emerging technologies and propose innovative assay formats and automation strategies.
• Design, optimize, and validate qPCR assays for infectious diseases and cancer markers.
• Oversee NGS-based panel development for oncology, microbial genomics, and resistance profiling.
• Develop robust sample-to-result workflows, including nucleic acid extraction, amplification, detection, and data analysis.
• Ensure analytical and clinical validation meets regulatory standards (IVD, CE-IVD, US FDA, WHO).
• Develop and implement Quality by Design (QbD) in assay development.
• Build and mentor a multidisciplinary R&D team and foster collaboration across departments.
• Oversee documentation in compliance with ISO 13485, IVDR, and CLIA; support regulatory submissions and audits.

Skills

qPCR

NGS

Molecular assays

Regulatory knowledge

Bioinformatics

Team leadership

Tools

qPCR machines

NGS platforms

Bioinformatics tools

LIMS

Job description

• Lead the molecular assay development department, providing scientific and operational direction.
• Define the R&D roadmap for molecular diagnostics aligned with company strategy.
• Evaluate emerging technologies and propose innovative assay formats and automation strategies.
• Design, optimize, and validate qPCR assays for infectious diseases and cancer markers.
• Oversee NGS-based panel development for oncology, microbial genomics, and resistance profiling.
• Develop robust sample-to-result workflows, including nucleic acid extraction, amplification, detection, and data analysis.
• Ensure analytical and clinical validation meets international regulatory standards (IVD, CE-IVD, US FDA, WHO, etc.).
• Develop and implement Quality by Design (QbD) principles in assay development.
• Build and mentor a multidisciplinary R&D team (molecular biologists, bioinformaticians, validation scientists, technicians).
• Foster a collaborative environment across R&D, Regulatory Affairs, Quality, and Manufacturing teams.
• Oversee documentation (Design History Files, validation reports, SOPs) in compliance with ISO 13485, IVDR, and CLIA requirements.
• Support regulatory submissions and audits by providing technical documentation and justifications.
• Collaborate with bioinformatics teams for assay design, data analysis, and pipeline development.
• Interface with clinical affairs for clinical trial design and sample sourcing.

Work closely with manufacturing to scale up assays and transfer validated methods into production.

Preferred candidate profile

Candidate should have minimum 13 - 15 yrs of handson experience in Molecular Assay Development based on RT PCR, quantitative PCR (qPCR) and Next-Generation Sequencing (NGS)technologies.