Manager – R&D (Molecular Diagnostics)

Bharrgava TetraMedEx; Delhi; Vor Ort; INR 1.350.000 - 1.650.000; Vollzeit

Zusammenfassung

Bharrgava TetraMedEx in Faridabad seeks a Manager – R&D (Molecular Diagnostics) to lead design, development, and commercialization of advanced molecular diagnostic workflows, with emphasis on Real-Time PCR and nucleic acid isolation.

The role ensures regulatory validation, prepares SOPs, and facilitates transfer to high-volume manufacturing while mentoring cross-functional teams and ensuring product dossiers meet ISO 13485 standards.

Qualifikationen

• Hands-on diagnostic assay development from design to validation.
• Experience with Real-Time PCR and nucleic acid purification.
• Familiarity with ISO 13485 and IVD manufacturing.

Aufgaben

• Design and optimize qPCR assays for diseases and oncology markers.
• Validate analytical and clinical performance per regulatory standards.
• Prepare SOPs and manufacturing guidelines for test kits.

Kenntnisse

Real-Time PCR

Primer design

Probe design

Nucleic acid purification

Assay development

qPCR instrumentation

Ausbildung

M.Sc./M.S. in Molecular Biology / Molecular Diagnostics / life sciences

Ph.D. in Immunology / Microbiology / Biochemistry / Biotechnology / Genetics / Pathology

Tools

Bioinformatics platforms

RT-PCR instruments

ISO 13485 knowledge

Jobbeschreibung

Position: Manager – Research & Development (Molecular Diagnostics)Department: R&D – Molecular DiagnosticsLocation: FaridabadEmployment Type: Full-time, PermanentCompensation: Up to ₹15 LPA (Commensurate with experience

Job Purpose

The Manager – R&D (Molecular Diagnostics) will drive the design, development, and commercialization of advanced molecular diagnostic workflows. This position leads hands-on assay development projects, focusing primarily on Real-Time PCR (qPCR) systems and nucleic acid isolation methodologies. The manager ensures all R&D outputs meet regulatory validation criteria and seamlessly transfer to high-volume manufacturing.

Key Responsibilities

1. Assay Design & Development
   • Design and optimize robust Real-Time PCR (qPCR) assays for infectious diseases, genetic profiling, or oncology markers.
   • Perform primer and probe designing using bioinformatics platforms while ensuring target specificity.
   • Develop and improve chemical master mixes and manual or automated nucleic acid purification processes.
2. Validation & Regulatory Compliance
   • Create and validate analytical and clinical performance protocols according to international and domestic regulatory frameworks.
   • Author detailed product dossiers, technical validation metrics, Design History Files (DHF), and compliance documentation.
   • Formulate clear Standard Operating Procedures (SOPs) and manufacturing guidelines for newly developed test kits.
3. Application & Technical Support
   • Provide second-level application support to resolve complex diagnostic anomalies escalated by field specialists.
   • Troubleshoot complex assay variations regarding extraction efficiency, analytical sensitivity, or instrument integration errors.
   • Train cross-functional teams and corporate stakeholders on final assay parameters and operating protocols.

Requirements & Qualifications

Educational Background

Postgraduate (Minimum): M.Sc. / M.S. in Molecular Biology, Molecular Diagnostics, or a tightly integrated life sciences field.

Doctorate (Preferred): Ph.D. in Immunology, Microbiology, Biochemistry, Biotechnology, Genetics, Pathology, or a related discipline.

Experience Parameters

Mandatory Background: Extensive hands-on industry experience in diagnostic assay development from initial design through validation phase.

Technical Depth: Demonstrated skill in extraction chemistry, multiplex primer/probe parameters, and operating RT-PCR instruments.

Regulatory Exposure: Clear familiarity with cleanroom protocols, quality frameworks (ISO 13485), and IVD manufacturing dynamics.