Head R&D; (IVD)

Job highlights

• 10+ years of experience in IVD product development,with expertise in RT-PCR and molecular diagnostics
• requirements: PhD / Master s in Molecular Biology,Biotechnology,Biochemistry,or related field

We are seeking a highly experienced and visionary Head of RD; (IVD) to lead the design and development of cutting-edge molecular diagnostic solutions at Genes2Me Pvt.
Ltd.
This role requires strong expertise in RT-PCR and molecular POC-based IVD product development, with the ability to provide scientific leadership, drive innovation, and ensure compliance with design control processes.
You ll work with cross-functional teams and external collaborators to deliver robust, reliable, and impactful diagnostic products.
requirements: PhD/Master s in Molecular Biology, Biotechnology, Biochemistry, or related field.
10+ years of experience in IVD product development, with expertise in RT-PCR and molecular diagnostics.
Strong background in experimental design, data analysis, analytical validation, and clinical validation.
Proven leadership in managing RD; teams and multi-project execution.
Familiarity with regulatory guidelines and design control processes for IVD.
Excellent problem-solving, project management, and communication skills.
benefits: Lead RT-PCR and molecular POC-based IVD product development under design control.
Provide technical expertise in product design, experimental planning, execution, and data analysis.
Ensure product robustness and performance through stability/analytical validation and clinical validation studies.
Develop and implement QC procedures for critical reagents and processes.
Lead development of Polymerase and Lyophilization for molecular diagnostic applications.
Translate customer and market needs into product requirements and technical specifications.
Define project plans, deliverables, milestones, and risk mitigation strategies across multiple product development programs.
Manage cross-functional project execution with RD;, applications, product management, and external collaborators.