Head, Lateral Flow Assay (LFA)

Job Description

ql-editor "> Head, Lateral Flow Assay (LFA) Team Roles & Responsibilities Direct the end-to-end development of quantitative/qualitative lateral flow assays (LFAs) with a strong emphasis on colloidal gold-based technologies, from concept through commercial launch. Develop and implement project plans, ensuring timely delivery of milestones and final products to the commercial market. Build, mentor, and manage a multidisciplinary team of scientists, engineers, and technicians; foster a collaborative environment that encourages innovation and professional growth. Coordinate with manufacturing, quality assurance, and regulatory teams to ensure robust assay design, process optimization, and regulatory compliance. Guide assay optimization, troubleshooting, and validation, with a focus on enhancing sensitivity, specificity, and reproducibility of quantitative LFA platforms. Allocate resources efficiently, manage budgets, and ensure procurement of critical raw materials and reagents for assay development. Provide regular project updates to senior management and stakeholders; prepare technical reports and presentations as needed. Drive process improvements and implement best practices for assay development, scale-up, and transfer to manufacturing. Identify project risks and develop contingency plans to ensure on-time delivery and high-quality outcomes. Candidate Qualifications Education: PhD or Master s degree in Biochemistry, Biotechnology, Analytical Chemistry, or a related field. Experience: Minimum 8+ years of hands-on experience in lateral flow assay development, with a proven track record of delivering quantitative colloidal gold-based products to the commercial market. Experience with fluorescence-based assays is a plus. Regulatory & Quality Understanding: Familiarity with IVD regulatory requirements (CDSCO and CE-IVD), quality management systems (e.g., ISO 13485), and design transfer to manufacturing. Communication: Excellent verbal and written communication skills; ability to convey complex technical concepts to diverse audiences. Problem-Solving: Strong analytical and troubleshooting skills, with the ability to resolve technical and operational challenges quickly and effectively. Commercial Acumen: Experience working with cross-functional teams to bring diagnostic products from R&D through to successful market launch.