Team Leader, Pilot Plant Support and Analytical Equipment Validation

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.

• 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.
• 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.

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

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.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

• competitive salary
• annual bonus based on company performance
• healthcare and wellbeing programmes
• pension plan membership
• shares and savings programme
• Performance with Choice programme offers a hybrid working model
• Discover more about our company wide benefits and life at GSK

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.

Adjustments@gsk. com where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

However, we have created a Recruitment FAQ guide.

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