Head of Advanced Therapies ProductionNHS

Job summary

The post holder will be responsible for managing production activities within the Unit and will lead the development and production of the current manufacturing campaigns as well as new manufacturing processes. The post holder will also be responsible for the programme of work centred around managing infrastructure, systems and procedures to ensure compliance with current UK and Trust requirements. This will also include responsibility for developing and implementing policies and standard operating procedures for manufacturing and, along with the Head of Quality, quality assurance of the GMP Unit.

Main duties of the job

The post holder will be responsible for the day to day management, operation, scheduling and administration of the production processes of the GMP Unit ensuring that it is operated and maintained as required by the Unit's licences. The post holder will also ensure that all products are manufactured and stored according to appropriate guidelines helping to ensure products are fit for their intended use with respect to safety and quality.

Job description

• Named as the Production Manager on the GMP units MHRA manufacturing authorisation.
• Develop, maintain and manage production schedules in line with the units budget.
• Design, deliver and provide relevant training courses to meet the needs of unit staff and users.
• Develop required manufacturing process for manufacturing campaigns and develop and maintain required documentation and specification files.
• Assist collaborators and users with Clinical Trial Authorisation submissions including the Investigational Medicinal Product Dossier.Conduct procurement in line with GMP requirements and the Trust processes.
• Along with the Head of Quality, ensure that the maintenance, operation, cleaning and validation of the Unit and equipment are completed in compliance with units stated procedures and standards, including obligations in the units Validation Master Plan and Planned Preventative Maintenance plan.
• Establish, implement and ensure adherence to the quality management system.
• Provide line management for key GMP Production staff and lead on recruitment, induction, appraisal, training and development and retention of production staff.
• Represent the Trust at national and international meetings, presenting the Unit and its work, so as to highlight the benefits of using the Unit to the ATMP sector
• Play a key role in developing new business of the unit and building a pipeline of income generating manufacturing campaigns.

About us

The R&D Department at Guy's & St Thomas' NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD.

Research is a top priority for the Trust which in 2024/25 was the top NHS organisation nationally for the number of NIHR portfolio studies open (554) and was the 6th highest recruiting Trust nationally recruiting over 24,000 participants into NIHR portfolio studies. This is approximately over 30% of the total number of participants of research studies within our Research Delivery Network in South London. For the financial year 2022/23, the NIHR budget for the R&D Department totalled approximately £22.6m. We are the most active research partner in the King's Health Partners Clinical Trials Office for contract commercial clinical trials with over 60% of the commercial trials portfolio in 2024/25 lead by the Trust.