General Manager - R&D (Molecular Diagnostics)

Transasia Bio Medicals; Visakhapatnam; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Transasia Bio Medicals is seeking a senior leader to head the molecular assay development department, steering R&D and aligning with corporate strategy. You will guide qPCR and NGS initiatives, validate assays, and ensure regulatory compliance across IVDR, CLIA, and FDA standards.

The role requires building a cross-disciplinary team and collaborating with Regulatory, Quality, Manufacturing, and Clinical affairs to deliver scalable, robust diagnostics workflows.

Qualifications

• Hands-on experience in molecular assay development using qPCR and NGS.
• Experience leading or building an R&D team.
• Familiarity with ISO 13485, IVDR, CLIA or regional regulatory standards.

Responsibilities

• Lead the molecular assay development department with scientific and operational direction.
• Define the R&D roadmap for molecular diagnostics aligned with company strategy.
• Evaluate emerging technologies and propose 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 extraction, amplification, detection, and data analysis.
• Ensure validation meets international regulatory standards (IVD, CE-IVD, US FDA, WHO).
• Implement Quality by Design (QbD) in assay development.
• Build and mentor a multidisciplinary R&D team.
• Foster collaboration across R&D, Regulatory, Quality and Manufacturing.
• Oversee documentation (DHFs, validation reports, SOPs) in line with ISO 13485, IVDR, CLIA.
• Support regulatory submissions and audits with technical documentation.
• Collaborate with bioinformatics teams for assay design and data analysis.
• Interface with clinical affairs for trial design and sample sourcing.
• Work with manufacturing to scale up assays and transfer methods to production.

Skills

Molecular biology

qPCR

NGS

Bioinformatics

QbD

Job description

Role & responsibilities

• 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 handson experience in Molecular Assay Development based on quantitative PCR (qPCR) and Next-Generation Sequencing (NGS)technologies.