Key Responsibilities:

• Lead the development and validation of novel lateral flow assays for in-vitro diagnostics (IVD), focusing on assay sensitivity, specificity, and reproducibility.

• Design, optimize, and scale-up LFA systems, including integration of critical assay components and control systems.

• Collaborate with cross-functional teams (mechanical, software, and sourcing) to ensure the smooth transition of assay designs from R&D to production.

• Troubleshoot and refine assay development processes, addressing key performance parameters to meet regulatory standards.

• Identify and collaborate with external vendors for material sourcing, assay customization, and large-scale production.

• Conduct rigorous system and subsystem performance evaluations using clinical samples, both in laboratory and field settings.

• Maintain detailed and accurate records of experimental protocols, data analysis, and interpretation in line with best lab practices.

• Drive strategic collaborations for acquiring and validating clinical samples (blood, urine, serum, etc.) for diagnostic assay testing.

  Required Qualifications:

• Masters or PhD in Biotechnology, Biochemistry, or related Life Sciences with 5+ years of industry experience in LFA or IVD product development.

• Proven expertise in lateral flow assay design, protein detection methods (ELISA, immunochemistry), and experience with biomarkers or bioassays.

• Strong laboratory skills in assay development, antibody conjugation, protein purification, and assay troubleshooting.

• Experience in identifying and overcoming technical challenges in assay performance and scalability.

  Preferred Skills:

• Demonstrated leadership in LFA development, including experience in clinical diagnostics and regulatory compliance.

• Proficiency in statistical analysis tools (e.g., Excel, R, or equivalent) for assay data interpretation.

• Strong project management skills, with experience in collaborating across multidisciplinary teams.

• Excellent written and verbal communication skills, with a demonstrated ability to document complex protocols clearly.