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Job Description
Join Our Team as a Production Study Manager
Are you an experienced GMP leader with a passion for clinical manufacturing? If you thrive in a fast paced, regulated environment and enjoy leading people while delivering high quality clinical studies, we’d love to hear from you.
We are looking for a confident and experienced Production Study Manager (PSM) to join our Manufacturing Operations team in Nottingham. This is a key leadership role, providing day to day oversight of GMP manufacturing activities and supporting the delivery of clinical trial materials.
What You’ll Be Doing
As a Production Study Manager, you’ll lead a manufacturing colour team and play a central role in ensuring investigational medicinal products (IMPs) are manufactured, labelled, and supplied safely, compliantly, and on time.
Your responsibilities will include:
Leading manufacturing operations, ensuring compliance with regulatory requirements and internal quality systems
Managing and developing a manufacturing colour team, providing clear direction, coaching, and support.
Overseeing cleanroom operations, facilities, and equipment to ensure inspection readiness at all times
Reviewing and approving documentation, including batch records, CMC documentation, GMP/GCP handover documents, and IMP labels
Acting as a technical escalation point for manufacturing issues, deviations, and quality events. Leading and supporting investigations, including root cause analysis and CAPA implementation
Ensuring studies are aligned with manufacturing schedules and operational capacity
Collaborating cross functionally, particularly with Development, QA and Clinical Operations, to ensure smooth transition from DEV to CTM to clinic
Manufacturing IMPs to the required standards for 40% of the working week.
Providing flexible technical support, including occasional out of hours cover, to maintain continuity of GMP operations
Who We’re Looking For
We’re looking for a motivated and experienced GMP professional who brings both technical expertise and people leadership.
Ideally, you will have:
5+ years’ experience in a supervisory or leadership role within a pharmaceutical GMP manufacturing and/or development environment
A degree in a scientific discipline (or equivalent relevant experience)
Strong line management or technical leadership experience in a regulated setting
Experience in a client facing role, with the ability to confidently communicate technical and quality information
A calm, solutions focused approach when working under pressure
Excellent organisational and communication skills, with strong attention to detail
Why Join Us?
Make a real impact – Play a key leadership role in delivering clinical trial materials that support the development of life changing medicines.
Lead with purpose – Take ownership of GMP manufacturing operations and directly influence quality, compliance, and patient safety.
Develop your career – Join an organisation that supports professional growth, leadership development, and progression within a regulated environment.
Share your expertise – Be part of a supportive, cross functional team that values open communication, expertise, and shared success.
Varied and engaging work – Work across multiple studies and dosage forms, offering variety, challenge, and continuous learning.
Stability with pace – Enjoy the security of an established organisation while working in a dynamic, fast moving clinical manufacturing environment.
