Analytical QC Lead: Transfer, Validation & Innovation

Pharmaron; Cramlington; On-site; GBP 70,000 - 95,000; Full time

Job summary

Pharmaron in the UK is seeking an Analytical Quality Control Team Leader in Cramlington to provide scientific leadership and manage a team of analysts in GMP QC labs. You will oversee method transfer, qualification and validation for new product introductions and ensure readiness of analytical methods, equipment and documentation.

The role requires a Chemistry degree and at least eight years in a regulated lab, with strong analytical chemistry expertise, experience with lifecycle management, and

Qualifications

• Degree in Chemistry or related discipline.
• 8+ years in a regulated industrial laboratory.
• Strong analytical chemistry expertise.
• Experience with analytical lifecycle management and method transfer into GMP QC labs.
• Experience leading method development, transfer, qualification and validation.
• Experience authoring protocols, reports and technical documentation.
• Understanding of GMP, GxP and ICH regulations.
• Proven ability to lead teams and manage multiple priorities.

Responsibilities

• Lead analytical method transfer, verification, qualification and validation activities to support new product introductions within GMP QC laboratories.
• Identify analytical risks and develop effective mitigation strategies to support successful project delivery.
• Drive continuous improvement of analytical lifecycle management, QC readiness activities and method transfer processes.
• Develop and maintain analytical project plans, ensuring milestones and deliverables are achieved on schedule.
• Ensure QC laboratory readiness, including analytical methods, specifications, equipment, reference standards, reagents, training and supporting documentation.
• Act as the primary Analytical QC representative within multidisciplinary project teams and serve as the QC lead for assigned product introduction programmes.
• Provide scientific expertise to solve complex analytical and technical challenges.
• Ensure compliance with cGMP, GxP, ICH guidelines, Quality Management Systems and all applicable regulatory requirements.
• Promote a strong quality culture across the team, reinforcing that quality is everyone's responsibility.

Skills

Leadership

Analytical chemistry

Regulatory knowledge

GxP expertise

Problem solving

Education

Chemistry degree

Job description

Pharmaron in the UK is seeking an Analytical Quality Control Team Leader in Cramlington to provide scientific leadership and manage a team of analysts in GMP QC labs. You will oversee method transfer, qualification and validation for new product introductions and ensure readiness of analytical methods, equipment and documentation.

The role requires a Chemistry degree and at least eight years in a regulated lab, with strong analytical chemistry expertise, experience with lifecycle management, and