Lead Scientist

Location Bath
Discipline: Science
Job type: Permanent
Salary: £45000 - £65000 per annum
Contact name: Kisha Addy

Contact email: kisha.addy@pro-tech.co.uk
Job ref: 57297_1752064990
Published: 2 days ago
Expiry date: 09 Aug 2025 00:59

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.





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