General Manager - R&D; Molecular Diagnostics

Position: General Manager - R&D (Molecular Diagnostics)
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, 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.