# Head of Advanced Therapies Production **Company**: Guy's and St Thomas' NHS Foundation Trust **Location**: London **Work arrangement**: onsite **Experience**: senior **Salary**: £66,274 to £73,496 a year **Category**: Healthcare **Industry**: Healthcare **Apply**: https://www.jobs.nhs.uk/candidate/jobadvert/C9196-26-1210?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_23ebecf1-258 ## Description 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. 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. **Main duties of the job** - 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. **Person Specification** - Qualifications / Education: + Essential: Education to post graduate degree level in appropriate subject area - MSc or equivalent experience. + Desirable: PhD or equivalent qualification. - Previous Experience: + Essential: Considerable experience of managing production, qualification, quality and documentation activities in a GMP environment. Proven experience of managing complex production schedules in a GMP environment and ensuring the implementation of operating procedures and efficient record keeping. Extensive experience in a supervisory role. This includes the ability to lead, develop, motivate and manage a team of production scientists. Strong project management experience. In depth understanding and experience of cell therapy processes. + Desirable: In depth understanding and experience of tissue engineered products, dissolution, sterilisation by filtration and small scale manual aseptic filling. - Skills, Knowledge and Ability: + Essential: In depth understanding of legislative framework of MHRA, HTA and H&SE in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials. Knowledge of Good QC Laboratory Practice and routine in-process controls (IPC) and QC assay techniques. Good communication skills both verbally and in written form. Strong organisational skills with a proven ability to manage competing demands. Commercially aware and able to manage procurement, and contracts. + Desirable: 20L disposable bioreactors, small scale chromatography, small scale Micro and Ultrafiltration, hand filling into vials. ## Skills ### Required - GMP - MHRA - HTA - H&SE - Good Manufacturing Practice - cell therapy processes - project management - quality management ### Nice to have - tissue engineered products - dissolution - sterilisation by filtration - small scale manual aseptic filling - 20L disposable bioreactors - small scale chromatography - small scale Micro and Ultrafiltration --- Source: [Apply at jobs.nhs.uk](https://www.jobs.nhs.uk/candidate/jobadvert/C9196-26-1210?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)