General Manager - R&D (Molecular Diagnostics)

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.