Team Leader Laboratory - PM Shift

JenaValve is a global medical device company focused on developing and manufacturing innovative Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of patients with severe aortic regurgitation and aortic stenosis.

Our mission is to raise awareness of aortic regurgitation and transform treatment options for patients living with this condition.

Our Leeds manufacturing facility produces the proprietary porcine pericardial tissue valves used within the JenaValve TAVR System.

Joining JenaValve means becoming part of a team that is dedicated to delivering high-quality medical devices and supporting advancements in patient care across the world.

We are looking for an experienced Laboratory Team Leader to supervise, coach and coordinate our Chemistry and Microbiology Laboratory PM team.

This role is responsible for ensuring testing activities are carried out effectively to support business operations and regulatory requirements. You will use laboratory data to identify risks, support investigations, drive improvements and provide technical guidance to the wider organisation.

Working closely with the Laboratory Manager and AM Shift team, you will help ensure seamless communication across shifts while maintaining the highest standards of quality, compliance and operational performance.

As Team Leader your responsibilities will include:

• Leading, supervising and developing the PM Shift Laboratory team.
• Planning daily laboratory activities, assigning work and managing staffing priorities.
• Providing coaching, training and performance feedback to support team development and accountability.
• Acting as the laboratory subject matter expert in the absence of the Laboratory Manager and providing technical support where required.
• Working closely with the Laboratory Manager to prioritise and execute laboratory workloads in line with operational requirements.
• Coordinating testing activities including:

• Analysis of glutaraldehyde and formaldehyde-based solutions using HPLC.
• Bioburden testing.
• Environmental monitoring programmes.
• Laboratory method development, qualification, validation and transfer.
• Analyst training and certification.
• Laboratory equipment calibration, maintenance and qualification.
• Data generation and analysis supporting business projects.

• Supporting protocol development, report writing and delivery of laboratory data.
• Providing ongoing visibility of laboratory activities, deviations and project progress to the Laboratory Manager.
• Monitoring and trending data to identify actual and potential non-conformances.
• Driving continuous improvement initiatives relating to laboratory practices, contamination control and operational efficiency.
• Facilitating cross-functional discussions and supporting data-driven decision making.
• Ensuring laboratory non-conformances are identified, documented and managed appropriately.
• Completing validation activities including Operational Qualification (OQ) and Performance Qualification (PQ).
• Supporting broader departmental and business objectives as required.
• Undertaking other reasonable duties requested by management.

• A Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, Biomedical Science or a related scientific discipline.
• A minimum of five years' experience within a Quality function in the medical device, pharmaceutical or other regulated industry.
• Hands-on analytical laboratory and/or microbiology experience.
• A minimum of three years' experience in a team leader or supervisory position.
• Strong knowledge of cGMP requirements and risk management principles.
• Working knowledge of Quality Management Systems and regulatory standards, including 21 CFR Part 820, ISO 13485 and/or pharmaceutical cGMP requirements.

• Strong people leadership and team development skills.
• The ability to coach, mentor and motivate individuals to achieve high performance.
• Excellent communication and relationship-building skills.
• The ability to work effectively across cross-functional teams.
• Strong technical writing skills and experience reviewing technical reports and investigations.
• The ability to interpret complex scientific and technical data and develop practical solutions.
• Strong risk assessment and risk management capabilities.
• Excellent problem-solving and decision-making skills.
• Experience identifying trends and using data to drive continuous improvement initiatives.
• Strong organisational skills with the ability to manage multiple competing priorities.
• A high level of attention to detail.
• The ability to work independently while recognising when escalation or management support is required.
• Experience preparing reports and communicating laboratory, quality and operational performance.
• Confidence communicating findings, risks and recommendations to both technical and non-technical stakeholders.

Salary: from £45,000 per year - plus 15% Shift Bonus

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus

• Monday to Friday 2.00pm to 10.00pm
• 37.5 Hours Per Week