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
