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Job details:
Job Description: R&D Head – Immunodiagnostics (LFIA)
Location: Noida, Uttar Pradesh (Initially); later based at Jewar, Uttar Pradesh
Experience: 8–10 Years
Reporting To: Plant Head
About Us
Avience Biomedicals Limited is an ISO and GMP-certified organization engaged in the manufacturing of IVD products, medical devices, biomedical consumables, and laboratory solutions, compliant with Indian MDR-2017, ISO 13485, FDA, and other global regulatory standards.
Job Summary
We are looking for an experienced R&D Head to lead the development, optimization, scale-up, and commercial manufacturing of immunodiagnostic assays, primarily Lateral Flow Immunoassays (LFIA). The role involves driving innovation, ensuring regulatory compliance, and leading cross-functional teams.
Key Responsibilities
- Lead the development and commercialization of LFIA-based diagnostic products.
- Optimize assay components, reagent formulations, conjugation chemistry, and manufacturing processes.
- Manage pilot-scale and commercial batch production, process validation, and technology transfer.
- Oversee critical operations, including colloidal gold conjugation, membrane coating, pad treatment, strip processing, and final assembly.
- Investigate manufacturing deviations and implement corrective actions.
- Ensure compliance with ISO 13485, GMP, Indian MDR-2017, FDA, and other regulatory requirements.
- Maintain technical documentation, SOPs, and validation records.
- Collaborate with QA, QC, Regulatory, and Supply Chain teams.
- Lead and mentor multidisciplinary R&D and production teams to achieve scientific, operational, and quality objectives.
Qualifications & Experience
- Ph.D. / M.Tech. / M.Sc. in Biotechnology, Biochemistry, Immunology, Life Sciences, or related fields.
- 8–10 years of experience in immunodiagnostic assay development and manufacturing, preferably in LFIA.
- Strong knowledge of assay development, process scale-up, validation, and regulatory compliance.
- Proven leadership, analytical, and problem-solving skills.
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