R&D Manager (New Delhi)

R&D Manager (New Delhi)

15 Aug
|
AVIENCE
|
New Delhi

15 Aug

AVIENCE

New Delhi

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.
Robust knowledge of assay development, process scale-up, validation, and regulatory compliance.
Proven leadership, analytical, and problem-solving s

📌 R&D Manager (New Delhi)
🏢 AVIENCE
📍 New Delhi

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