Supply Chain and Warehouse Manager

The role of the Supply Chain and Warehouse Manager is to oversee and manage all logistical and supply chain activities at both the Cell and Gene Therapy Catapult's manufacturing centre at Stevenage and off site. Reporting to the Manufacturing Centre Director, this role will ensure that the supply chain, logistics and the warehouse, meets the standards and expectations of its key stakeholders; regulatory authorities; and collaborators.

The Supply Chain and Warehouse Manager will have experience of managing GMP supply chains and warehousing functions providing developed processes and systems to ensure a compliant and efficient operation and will provide expertise and oversight in ensuring IT systems required to operate a compliant GMP supply chain and warehousing operation are in place and are fit for purpose.

The Supply Chain and Warehouse Manager will manage the flow of goods/materials and services from third party logistic providers and Collaborators into the manufacturing centre; schedule and plan the storage, movement of raw materials, into manufacturing and the final transfer of finished products out of manufacturing and into short term storage and finally out of the facility to Collaborators and/or third party distributors.

The Supply Chain and Warehouse Manager will have the necessary experience in supply chain/warehouse management systems such as SAP, WMS to ensure the operational systems and broader processes fully comply with GMP requirements and needs of the unique business model at CGT Catapult.

The Supply Chain and Warehouse Manager will establish links with outside parties to benefit the CGT Catapult manufacturing centre and UK advanced therapy industry supply chain processes including identifying, evaluating & adapting new technologies where appropriate.

The role will include frequent communication and meetings with Collaborators, suppliers and external supply chain logistic providers in order to enhance processes and systems for advanced therapies for the Cell and Gene Therapy Catapult manufacturing centre and the UK. The Supply Chain and Warehouse Manager will be expected to provide supply chain and GMP warehousing training and education both internally and externally., Supply chain / logistics management:

• Manage all CGT Catapult supply chain and logistic service providers ensuring all are measured and are delivering according to agreed service levels.


• Work with the CGT Catapult teams, Collaborators and service providers to manage the selection and oversight of 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 as detailed in Collaboration Agreements and quality technical agreements.


• Develop the CGT Catapult manufacturing centre supply chain and warehouse systems to support an efficient and effective operation to ensure all CGT Catapult & Collaborator consumables, raw materials, excipients, product contact materials are supplied on time, stored, picked and shipped to the 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 are able to 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 in order to grow the UK Cell & Gene Therapy industry.


On & offsite inventory management:

• Manage the on-site inventory and/or service providers to efficiently and effectively develop & maintain the inventory between the offsite 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 the 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 which will support booking in, quarantine, release, rejection of goods, picking of materials/kits and shipment of final product work streams.


• Ensure that all temperature controlled storage facilities within the facility (both GMP and non-GMP) are managed and maintained according to internal policies and procedures.



• As required work with the 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 and support 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.


Regulatory:

• Ensure the supply chain and inventory management areas operates to a high standard and complies 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 the traceability of products from supply through manufacturing process to delivery of final products.


Management:

• 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 & 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 & 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 & 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 & CAPAs.


• Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.


• Proven experience of managing, leading, motivating teams, whilst 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 in interacting with the regulatory authorities.


• Experience in interacting with clients and collaborators.


• Personal development - Pursue a program of continuous personnel development in accordance with requirements of the position and any relevant professional registration or statutory requirements.


Knowledge / Skills / Competencies:

• Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to assist in the acceleration of the development of a commercial cell based therapy industry in the UK.


• Able to evaluate complex situations and find solutions for them in a professional manner.



• Excellent organisational skills with ability to prioritise work whilst dealing with high volume issues, changing priorities and tight deadlines.


• Accurate with a strong focus on attention to detail.


• Ability to work quickly and accurately, with limited supervision, good initiative taker.


• Having a passion for delivering excellent customer service in a cost effective way.


• Flexibility towards work assignments and new learning.


• Comfortable operating autonomously once goals and objectives are set.


• Excellent interpersonal, written and verbal communication skills.


• Having current and up to date professional knowledge, expertise and best practice.


• A good team player, with proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.


• Ability to quickly establish credibility and build rapport and trust., Desirable - degree qualified


• Member of a recognised professional body (Desirable)