Position Overview
Job 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, an...