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Production Manager
2 months ago
Production Manager
Permanent
Motherwell
Reporting to the Head of Production, the post holder will be responsible for the manufacture of GMP grade clinical product for cell therapy clinical trials. The post holder will provide management and leadership to any new or current Production supervisors, scientists and technicians within the team. They will oversee the day-to-day operations of the manufacturing process and work in close partnership with the other departments. In addition, they will also be responsible for ensuring the smooth introduction and technology transfer of all new processes to Production, the performance of the department from a quality and operational perspective and ensure the most effective use and utilisation of the staff and assets at their disposal. The post holder will exercise overall responsibility for good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
Responsibilities
Responsible for the manufacture of cell-based therapies for clinical use. This involves cell culture to GMP standards. The post holder will primarily oversee activities but may occasionally be required to enter the highly controlled cleanroom environment
Oversee the day-to-day management of all production operations, ensuring that suitable resource and expertise is employed to deliver the service in line with business objectives and regulatory guidelines.
Manage direct reports, assign tasks, monitor performance on a frequent basis and support their personal development including instilling the necessary attitude and behaviours for the achievement of production efficiency and continuous improvement. Assist in development and setting on individual targets for the team as appropriate and ensure that regular feedback is given.
Organising the team to ensure project milestones are met. Where project milestones cannot be met, responsible for the communication of such instances to line management.
Ensure all manufacturing activities are undertaken in accordance with the registered product requirements and to current regulatory and quality standards.
From a production perspective be responsible for ensuring the appropriate technology transfer of new platforms and products and/or new manufacturing processes and techniques is agreed upon and is implemented successfully to deliver improvement in either safety, quality, capacity or capability of the department. Ensure that staff are suitably trained in both the process technologies and key process parameters relevant to all new products.
Perform problem solving/trouble shooting of cell culture production processes by identifying issues and implementing procedures in accordance with GMP and relevant regulatory standards and in accordance with QMS.
Qualifications
A degree in a relevant life sciences discipline, or related subject area.
Leadership experience as a line manager with direct reports.
Knowledge of day to day running of MHRA regulated GMP cleanroom environment.
Experience in cell culture, cell banking and aseptic techniques is preferred.
Familiarity with environmental monitoring systems and experience in organising APS is preferred.
Experience in management and progression of quality records including deviations, change controls and quality risk assessments.
Experience in reviewing, updating and creating relevant GMP documentation.
