Production Study Manager in Nottingham

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform - "Translational Pharmaceutics" - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.

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

• 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.

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.