Principal Scientist – Lateral Flow Assay New

You will collaborate with cross-functional teams to ensure the seamless transition of assay designs from R&D to production, and contribute to advancing diagnostic solutions that improve patient outcomes.

Key Responsibilities:

• Lead the development and validation of novel lateral flow assays focusing on assay sensitivity, specificity, and reproducibility.
• Design, optimize, and scale up LFA systems, integrating critical assay components and control systems to ensure robust performance.
• Troubleshoot and refine assay development processes to meet regulatory standards and address key performance parameters.
• Collaborate with cross-functional teams (mechanical, software, sourcing) to facilitate smooth technology transfer from R&D to production.
• Identify and work with external vendors for material sourcing, assay customization, and large-scale manufacturing.
• Conduct comprehensive system and subsystem performance evaluations using clinical samples in both lab and field environments.
• Maintain meticulous records of experimental protocols, data analyses, and interpretations in line with best lab practices.
• Drive strategic collaborations for acquiring and validating clinical samples such as blood, urine, and serum.

Required Qualifications:

• Master’s or PhD in Biotechnology, Biochemistry, or related Life Sciences field.
• Minimum 5 years industry experience in lateral flow assay or in-vitro diagnostic product development.
• Expertise in lateral flow assay design, protein detection methods (ELISA, immunochemistry), and experience with biomarkers or bioassays.
• Strong laboratory skills including antibody conjugation, protein purification, and assay troubleshooting.
• Proven ability to identify and overcome technical challenges related to assay performance and scalability.

Preferred Skills:

• Demonstrated leadership in LFA development, with experience in clinical diagnostics and regulatory compliance.
• Proficiency in statistical analysis tools such as Excel, R, or equivalents for data interpretation.
• Strong project management skills and experience working collaboratively across multidisciplinary teams.
• Excellent written and verbal communication skills, with the ability to clearly document complex protocols and present results effectively.