Logistics and Operations Manager

We are seeking an experienced Logistics and Operations Manager to oversee our supply chain and warehouse operations at our manufacturing centre in Stevenage. As a key member of our team, you will be responsible for ensuring the efficient management of goods/materials and services from third-party logistic providers and Collaborators into the manufacturing centre.

The ideal candidate will have previous experience in managing GMP supply chains and warehousing functions, providing developed processes and systems for a compliant and efficient operation. You will also have expertise in ensuring IT systems required to operate a compliant GMP supply chain and warehousing operation are in place and fit for purpose.

You will work closely with our teams, Collaborators, and service providers to manage supplier and vendor performance, including assistance during supply chain audits. Your role will involve collaborating with and ensuring processes and systems are implemented and are fit for purpose to allow the use of third-party logistic providers (3PLs) to support the supply of Collaborator and CGT Catapult materials and kits according to agreed standards.

In this role, you will develop the CGT Catapult manufacturing centre supply chain and warehouse systems to support an efficient and effective operation, ensuring all CGT Catapult & Collaborator consumables, raw materials, excipients, product contact materials are supplied on time stored picked and shipped to required quality standards.

Key Responsibilities:

• Manage all CGT Catapult supply chain and logistic service providers ensuring they deliver according to agreed service levels.
• Work with CGT Catapult teams, Collaborators, and service providers to manage supplier and vendor performance including assistance during supply chain audits.
• Collaborate with and ensure processes and systems are implemented and are fit for purpose to allow the use of third-party logistic providers (3PLs) to support the supply of Collaborator and CGT Catapult materials and kits according to agreed standards.
• Develop the CGT Catapult manufacturing centre supply chain and warehouse systems to support an efficient and effective operation ensuring all CGT Catapult & Collaborator consumables, raw materials, excipients, product contact materials are supplied on time stored picked and shipped to required quality standards.
• Implement and manage robust scheduling and planning tools to support expected increase in Collaborator companies and material movements throughout the facility ensuring the supply chain and logistics group can support a high-throughput manufacturing operation at the manufacturing centre.
• Set up and ensure adherence to chain of custody procedures.
• Work with internal CGT Catapult teams and external supply chain operations to implement best practice and operational improvements.
• Participate and lead external/national supply chain initiatives to grow the UK Cell & Gene Therapy industry.

• Manage the on-site inventory and/or service providers to efficiently develop and maintain the inventory between off-site warehouse facilities and the onsite CGT Catapult manufacturing centre forward picking area to ensure all consumables raw materials excipients product contact materials and kits are supplied on time on budget and to required quality standard.
• Ensure all supply chain and warehousing policies and procedures for the CGT Catapult manufacturing centre are current and comply with regulatory expectations.
• Introduce and maintain GMP compliant warehouse management systems supporting booking in quarantine release rejection of goods picking of materials/kits and shipment of final product work streams.
• Ensure temperature-controlled storage facilities within the facility are managed and maintained according to internal policies and procedures.
• As required work with service provider(s) and Collaborators to implement a Bill of Materials (BoM) picking and delivery system integrated with the facility's WMS to support GMP batch manufacturing activities.
• Work with service providers to introduce and maintain a GMP-compliant system for general consumables stock - VSR+.
• Introduce a process/system for maintaining material cycle counts for all GMP material/storage locations.
• Establish and maintain strong relationships with Collaborators clinical site logistics and other service providers.
• Provide packaging and labelling activities to Collaborators for shipment of finished product from the Cell and Gene Therapy Catapult manufacturing centre to Collaborator clinical/commercial sites.

• Ensure the supply chain and inventory management areas operate to a high standard and comply with GMP and other regulatory standards.
• Generate review and approve cGMP documentation such as Standard Operating Procedures (SOPs) User Requirement Specifications (URS's) and validation/operator qualification protocols and reports.
• Ensure the CGT Catapult team and associated service providers complete all documentation and records accurately and to a GMP standard.
• Ensure traceability of products from supply through manufacturing process to delivery of final products.

• Manage relationships with key service providers and Collaborator supply chain groups to enhance advanced therapies at the MC and in the UK. Introduce and monitor KPIs to ensure performance is maintained and measured.
• Manage and lead the CGT Catapult supply chain/inventory management team including recruitment selection motivation training development appraisals and manage staff performance.
• Review and manage mc warehouse working practices to ensure delivery of the business model.
• Manage quality records effectively adhering to internal standards for investigation management and closure.
• Generate review and approve safety documentation such as Risk Assessments COSHH assessments Material Data Safety Sheets etc.
• Work within the CGT Catapult manufacturing centre multi-disciplinary team and matrix environment to ensure successful delivery of CGT Catapult/Collaborator projects. Liaise with Collaborators and other CGT Catapult teams to ensure resources are used efficiently and effectively.
• Manage the CGT Catapult supply chain/warehouse budget and escalate discrepancies/issues to line management.
• Keep senior management informed in a timely manner of any supply chain concerns or issues.
• Set up a supply chain continuous improvement system.

• Previous management experience of working in a GMP biopharmaceutical warehouse/inventory management environment.
• Previous experience of managing supply chain/logistic operations.
• Experience of operating multiple supply chain/logistic systems supporting a GMP warehouse/supply chain operation.
• Proven experience of writing and reviewing GMP documents E.g. MBR's SOPs change controls NC investigations and CAPAs.
• Proven experience of looking critically at own and others' work practices and procedures and identifying and implementing needed improvements.
• Proven experience of managing leading motivating teams while training and acting as a role model for all staff associated with the GMP warehouse facility.
• Experience of leading and/or assisting in recruiting and selecting new staff.
• Experience interacting with regulatory authorities.
• Experience interacting with clients and Collaborators.
• Personal development Pursue a program of continuous personnel development in accordance with requirements of the position.

• Degree qualified.
• Member of a recognised professional body.

The salary for this role is estimated to be around £70,000-£90,000 per annum, depending on experience.

This is a fantastic opportunity to join our team and contribute to the growth of the UK Cell & Gene Therapy industry.