Team Leader, Pilot Plant Support and Analytical Equipment Validation

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Team Leader, Pilot Plant Support and Analytical Equipment Validation UK (PPS AEV)

Job Purpose

Provide technical leadership and strategic oversight for  analytical cleaning verification and Pilot Plant support to clinical manufacturing operations.

The role is accountable for developing scientifically justified analytical cleaning methods, establishing health-based and process-based cleaning limits, and ensuring compliant implementation of cleaning verification programmes in partnership with manufacturing, quality and product development teams.

The position also provides analytical leadership for  blinded comparator testing and other Pilot Plant support activities, such as raw material release, to enable the progression of assets through clinical development.

The role combines scientific expertise with cross-functional leadership to ensure patient safety, regulatory compliance, operational efficiency, and successful execution of DDS clinical manufacturing programmes.

Key Responsibilities

• Lead and supervise scientists and specialists, ensuring effective team performance, development, and succession planning
• Lead the development and implementation of  analytical cleaning verification methods and analytical cleaning validation strategies  supporting Pilot Plant and clinical manufacturing operations.
• Establish scientifically justified cleaning limits using  health-based and Fourman & Mullen methodologies, ensuring alignment with regulatory expectations and GSK quality requirements.
• Solve complex technical and operational problems, facilitate team problem-solving, and make strategic decisions impacting departmental level
• Ensure computerised laboratory analytical equipment and systems used to support regulatory submissions to develop, test or manufacture materials within DDS, are qualified or validated as appropriate and maintained in an appropriately validated state in accordance with the relevant regulations, corporate policies and standards to ensure patient safety, product quality and data integrity.  .
• Lead the development, qualification, validation and transfer, where required, for analytical methods supporting cleaning verification and blinded comparator testing.
• Review and approve analytical data, protocols, reports and technical documents in compliance with GMP, corporate standards and data integrity requirements.
• Build strong partnerships across Analytical Development, Clinical Manufacturing, Quality, EHS and Regulatory functions to ensure effective delivery and compliance.
• Apply digital and data-driven approaches to improve efficiency, simplify business processes and enhance management of cleaning verification and manufacturing support activities.

Leadership Expectations

• Provide scientific leadership and coaching to analytical scientists supporting Pilot Plant programmes.
• Support inspection readiness and act as a subject matter expert during internal audits and regulatory inspections.
• Maintain awareness of evolving regulatory expectations and industry best practices relating to cleaning verification and validation.

Knowledge and Experience

Essential

• Experience supporting clinical manufacturing or pilot plant operations.
• Demonstrated experience / expertise in analytical cleaning verification and validation programmes within GMP environments.
• Experience developing, validating and transferring analytical methods.
• Experience in analytical equipment validation
• Ability to influence and lead cross-functional teams in a complex matrix environment.
• Experience reviewing and approving technical documentation and analytical data.
• Experience supporting regulatory submissions, inspections and audits.

Preferred

• Knowledge of blinded comparator testing and pharmaceutical product characterisation.
• Familiarity with digital, automation or data-driven solutions within analytical laboratories and manufacturing support environments.
• Subject matter expert for  analytical cleaning verification and validation, supporting Clinical Manufacturing.

Work Environment

 

This is a hybrid role with regular time in a UK office and flexibility to work remotely, in line with business needs and as agreed with the hiring manager.

 

How to apply

We welcome applications from people with different backgrounds and experiences. If this role speaks to you, please apply and tell us briefly how your skills and experience match the responsibilities and qualifications listed. We look forward to hearing from you.

Closing Date for Applications – 24/08/2026

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Skills

Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Automation Technology, Bioprocessing, Chemical Processes, Data Analysis Tools, Dosage Forms, Drug Development, Matrix Leadership, Method Development, Technical Problem-Solving

 

 

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

 

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

 

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

 

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

 

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

 

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