General Manager - R&D (Molecular Diagnostics) (Mumbai)

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 creative 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. Apply on Kit Job: kitjob.in/job/4lcn5v