We are seeking a highly skilled and motivated lateral flow assay (LFA) development scientist to lead the design, development, and validation of novel in-vitro diagnostic assays.
The ideal candidate will have deep expertise in assay sensitivity, specificity, and reproducibility, with a strong background in assay optimization and scale-up. 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.