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.
Key Responsibilities
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.
Skills & Experience - Essential
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.
Skills & Experience - Desirable
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