Lead Scientist

An established and growing company within the medical diagnostics industry is seeking a Lead Scientist to join their UK-based research and development team. This role involves leading the technical development of innovative molecular diagnostic products in a highly regulated environment.

The successful candidate will play a key role in developing next-generation point-of-care diagnostic assays, leading a small team of scientists, and managing projects from concept through to design transfer.

• Lead technical development for multiple R&D projects across the organisation.

• Line-manage a team of 2-3 assay development scientists.

• Design and execute complex experimental plans and review data for accuracy and quality.

• Develop technical strategies for assay optimisation using DOE and robust design principles.

• Act as a subject matter expert in experimental design and statistical analysis.

• Create and maintain technical documentation compliant with regulatory and quality standards (e.g., ISO 13485, ISO 14971).

• Ensure all activities meet internal quality and compliance requirements.

• Produce technical reports and contribute to product design decisions.

• Promote high standards of laboratory practice and scientific rigor.

• BSc with 7+ years or MSc/PhD with 5+ years of experience in molecular diagnostics or IVD development.

• Industrial experience developing NAAT-based assays (e.g., PCR, LAMP).

• Strong understanding of Design Control within a regulated framework (ISO 13485).

• Experience with risk management activities (ISO 14971).

• Proficiency in analysing and interpreting complex datasets.

• Track record in technical project management within a laboratory-based environment.

• Excellent communication and leadership skills.

• Advanced knowledge of Design of Experiments (DOE) and robust design principles.

• Experience with Minitab, JMP, MATLAB, Python, R, or similar tools.

• Lean Six Sigma certification or equivalent.

• Prior experience with design verification, validation, and design transfer.

• Experience working within Quality Management Systems in a regulated diagnostics environment.