Drug Product Project Coordinator - 12 Month Fixed Term Contract

Quotient Sciences; Alnwick; Sur place; GBP 32 000 - 46 000; Plein temps

Résumé du poste

Quotient Sciences is seeking a Drug Product Coordinator for a 12 month fixed term contract. The role supports drug product manufacturing across client projects, ensuring GMP-compliant documentation and efficient operations.

You will work with Manufacturing, Quality Control, Microbiology and Purchasing to deliver clinical manufacturing, packaging and labeling activities with a focus on compliance and operational excellence.

Qualifications

• Proven experience in pharmaceutical/biotech GMP environments.
• Ability to prepare, review and approve Batch Manufacturing Records and GMP documentation.
• Strong multitasking to manage multiple priorities and timelines.
• Excellent attention to detail with commitment to quality and compliance.
• Experience in inventory, materials or supply chain activities in a regulated setting is advantageous.

Responsabilités

• Coordinate activities to support manufacturing operations and delivery of clinical manufacturing projects and packaging activities.
• Prepare, review, and approve manufacturing documentation including Batch Manufacturing Records and packing instructions.
• Ensure all work is documented in compliance with regulatory requirements and client expectations.
• Manage GMP material inventories including ordering, receipt, storage and stock control.
• Liaise with Quality Control, Microbiology and Purchasing to ensure materials are available for schedules.
• Support investigations, deviations, change controls and other quality records.
• Promote high health and safety standards and safe working practices.
• Work flexibly across the site to support business priorities and operational requirements.
• Provide support and deputise for Head of Drug Product Operations when required.

Connaissances

Organisational skills

Attention to detail

Communication

Stakeholder management

Problem-solving

Description du poste

About the Role

This is a 12 month fixed term contract

We are seeking a highly organised and proactive Drug Product Coordinator to support the successful delivery of drug product manufacturing activities across a diverse range of client projects. This role is critical in ensuring manufacturing operations are coordinated efficiently, documentation is prepared and maintained to the highest GMP standards, and projects are delivered in compliance with regulatory and client requirements.

Working closely with cross-functional teams, including Manufacturing, Quality Control, Microbiology and Purchasing, you will play a key role in supporting clinical manufacturing, packaging and labelling activities while ensuring operational excellence throughout the product lifecycle.

Key Responsibilities

• Coordinate activities required to support manufacturing operations and ensure the successful delivery of clinical manufacturing (CMC and CTM) projects, along with IMP packaging and labelling activities.
• Prepare, review and approve manufacturing documentation, including Batch Manufacturing Records, packing instructions and associated GMP documentation.
• Ensure all work is documented accurately and completed in compliance with relevant regulatory requirements, internal procedures and client expectations.
• Manage and maintain GMP material inventories, including ordering, goods receipt, storage and stock control activities.
• Liaise effectively with Quality Control, Microbiology and Purchasing teams to ensure materials are available to support manufacturing schedules.
• Support the investigation, completion and approval of quality events, including deviations, change controls and other quality records.
• Promote and maintain high standards of health and safety, ensuring safe working practices are followed at all times.
• Work flexibly across the site to support business priorities and operational requirements.
• Provide support and deputise for the Head of Drug Product Operations when required.

Experience Required

• Experience working within a pharmaceutical, biotechnology or GMP-regulated manufacturing environment.
• Knowledge of GMP requirements and pharmaceutical manufacturing documentation.
• Experience preparing, reviewing and approving manufacturing records and controlled documentation.
• Strong organisational skills with the ability to manage multiple priorities and meet project timelines.
• Excellent attention to detail and a commitment to quality and compliance.
• Experience managing inventory, materials or supply chain activities within a regulated environment is advantageous.
• Strong communication and stakeholder management skills, with the ability to work effectively across multiple departments.
• A proactive and collaborative approach to problem-solving and continuous improvement.