Molecular Diagnostics jobs

Job Summary:

We are seeking a highly motivated and skilled R&D Reagent Specialist to join our innovative In Vitro Diagnostics (IVD) team. The successful candidate will play a key role in the research, development, and optimization of reagents for diagnostic applications, contributing to the design, formulation, and validation of novel diagnostic products for clinical use.

Key Responsibilities:

• Development of IVD Reagents: Design, develop, and optimize reagents for various in vitro diagnostic tests, including antibodies, enzymes, substrates, buffers, and other reagents critical to diagnostic assays.
• Formulation & Stability Studies: Conduct formulation studies, stability testing, and performance validation of reagents to ensure they meet regulatory standards and performance specifications.
• Process Development: Collaborate in the scale-up and manufacturing process development, ensuring that reagent formulations can be produced efficiently and consistently at commercial scale.
• Documentation and Reporting: Prepare detailed technical documentation, reports, and specifications for reagents, maintaining rigorous records of experimental data and results.
• Regulatory Compliance: Ensure that all reagent development processes comply with regulatory standards (e.g., ISO, CDSCO, CE marking) and support product registration and certification.
• Cross-Functional Collaboration: Work closely with cross-functional teams, including analytical chemistry, quality assurance, regulatory affairs, and clinical research, to ensure seamless development of IVD products.
• Troubleshooting and Problem-Solving: Investigate and resolve issues related to reagent performance, stability, and compatibility during product development and clinical trials.
• Technology Transfer: Assist in the transfer of reagents from R&D to manufacturing, ensuring that all specifications and requirements are met for product scalability.
• Market Research and Trends: Stay updated with the latest developments in the IVD field, including new technologies, reagents, and regulatory changes that could impact product development.

Qualifications:

• Education:
• A Master’s, or PhD in Life Sciences, Immunology, Proteomics , Biochemistry, Biotechnology, or a related field from reputed University or Research institutes
• Experience:
• Proven experience in reagent development for in vitro diagnostic (IVD) products or related industries (such as biopharma or medical devices).
• Experience with the formulation and optimization of reagents, assay development, and testing methodologies for diagnostics.
• Hands-on experience in laboratory techniques, such as immunoassays, PCR, ELISA, or other diagnostic assay methods.
• Skills & Competencies preferred;
• Understanding of IVD product development processes and regulatory requirements (e.g.ISO 13485).
• Experience in immunoassays, antigen antibody reaction along wth conjugation techniques.
• Knowledge of chemical, biochemical, and analytical methods used in reagent development.
• Ability to work independently and within cross-functional teams, with excellent communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Proficiency in office , data analysis, statistical methods, and scientific software tools
• Familiarity with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

Excellent communication skills are essential

Working Conditions:

• Full-time position.
• Laboratory-based role with possible travel to external partners, suppliers, or clinical sites.
• Compliance with health and safety regulations in laboratory settings.

Pay: From ₹50,000.00 per month

Benefits:

• Cell phone reimbursement
• Food provided
• Provident Fund

Work Location: In person