Analytical Laboratory Manager

R&D facility context

Position overview

Laboratory leadership and testing

• Lead, engage, and communicate with the Analytical team, including recruitment, employee development, coaching, and performance management.
• Set expectations, provide guidance, and identify development and training needs.
• Monitor team performance against KPIs and drive continuous improvement.
• Manage, prioritize, plan, coordinate, and oversee analytical testing.
• Support Technology and Innovation pipeline projects with technical and analytical development.
• Define and execute analytical method development, validation, and transfer strategies, including validation under relevant ICH guidelines.
• Provide technical guidance for research, troubleshooting, and manufacturing support.
• Keep abreast of scientific literature, emerging technologies, and alternative ways of working.

Quality, safety, and documentation

• Ensure methods and validation comply with internal procedures, applicable regulations and guidelines, and industry best practice.
• Review and approve analytical and technical documentation, including testing and validation protocols and reports, technical reports, standard operating procedures, and controlled documents.
• Identify and address out-of-specification results and non-conformances; ensure investigations, resolutions, and corrective actions are completed within agreed timeframes.
• Contribute as a functional laboratory leader to Design and Development projects conducted under Design Controls.
• Maintain safety standards and compliance with Environment, Health and Safety policies, laboratory quality systems, and processes.
• Ensure laboratory equipment is maintained, calibrated, and serviced; support equipment qualification and computerized-system validation for laboratory equipment software.
• Ensure risk assessments, safe systems of work, and Control of Substances Hazardous to Health assessments are in place.

Stakeholder and financial management

• Work with project and departmental managers to manage workloads, timelines, and priorities.
• Manage the departmental budget, including budget setting and expense management.
• Manage relationships with suppliers of analytical equipment, software, and services.

Skills and experience

• At least seven years of industry experience in a medical device or pharmaceutical laboratory environment.
• Proven management experience leading and developing a team of scientists.
• Working knowledge of FDA and European quality-system regulations relevant to medical devices or pharmaceuticals.
• Knowledge of drug-device combination product technologies is preferred.
• Sound understanding of product development processes and Design Controls.
• Experience planning and executing analytical method validation and method transfer activities.
• Strong Analytical Chemistry experience is preferred.