Analytical Quality Control Team Leader

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

Position: Analytical Quality Control Team Leader

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We’re proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.

About the Role

We are seeking an Analytical Quality Control Team Leader to join our team in Cramlington. This is an exciting opportunity for an experienced analytical scientist and people leader to play a key role in supporting new product introductions, analytical lifecycle management and GMP quality control operations.

Working within a multidisciplinary environment, you will provide scientific leadership and technical expertise, ensuring analytical methods are successfully transferred, qualified and validated within GMP QC laboratories. You will also lead and develop a team of scientists while driving continuous improvement, quality and client success.

At Pharmaron we offer:

• Vibrant and dynamic employment –we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
• Opportunities to develop your skills and yourself –our rapid growth brings greater opportunities for you to learn and grow faster!
• A great team where we all support each other –enjoy your work – after all you spend about a third of your time here!

Key roles and 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.

Requirements:

The following experience and qualifications are essential for success in this role:

• Degree or equivalent qualification in Chemistry or a related scientific discipline.
• Significant industrial laboratory experience, ideally gained over at least eight years within a regulated environment.
• Strong expertise in analytical chemistry and the application of analytical and physical science techniques to solve complex challenges.
• In-depth knowledge of analytical lifecycle management and method transfer into GMP Quality Control laboratories.
• Experience leading analytical method development, transfer, qualification and validation activities.
• Experience authoring and reviewing protocols, reports and technical documentation.
• Understanding of GMP, GxP and ICH regulatory requirements.
• Proven ability to lead teams and manage multiple priorities effectively.

Why Pharmaron?

Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

• Job Category Scientific (Analytical Development)