Head of Advanced Therapies Production

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.