Research Officer - Research and Development ( R&D ) Reagent …, Kerala

Department: Research and Development (R&D;) Reports To: R&D; Manager

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 Masters, 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 & Competenciespreferred;
- 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. Apply on Kit Job: kitjob.in/job/4n5uvn