OVERALL ROLE OBJECTIVE:

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 technical 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 INCLUDE BUT ARE NOT LIMITED TO:

Responsible for the manufacture of TC BioPharm’s portfolio of γδ T cell-based therapies for clinical use. This involves cell culture (including isolation, expansion and formulation) to GMP standards. The post holder will primarily oversee activities but may occasionally be required to enter the highly controlled cleanroom environment; therefore, individuals will need to be able to gown appropriately to EU GMP standards (Grades D to A).
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 behaviors 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 technical 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 TC BioPharm Quality Systems.
Champion high standards in production documentation ensuring that all procedures are documented and reviewed to appropriate quality standards including, but not limited to standard operating procedures, manufacturing batch records, investigations/deviations, technical transfer documentation and project documentation.
Lead quality investigations/deviations, perform root cause analysis and manage implementation of CAPA.
Manage the implementation of change and actions ensuring they are closed on time and department KPIs are adhered to.
Manage supporting activities including but not limited to CAPEX equipment planning/procurement, ensuring sufficient stock of reagents and consumables, maintaining calibration and servicing records, training records updated accordingly, ensuring equipment compliance and a clean, organised smooth production environment.
Ensure suitable metrics are applied to measure production resource utilisation and actual production costs. Provide a means by which the production costs are measured to support Finance in the preparation of department budgets. Conduct regular reviews of process efficiency and lead multifunctional teams as required to implement change management programmes as approved.
Ensure quality standards are maintained in compliance with GMP standards and that work is performed in accordance with the company’s QA and Health and Safety policies including the provision of COSHH/Risk assessments.

QUALIFICATIONS:

A degree in a relevant life sciences discipline, or related subject area.

SKILLS & EXPERIENCE:

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.
Ability to work without supervision.
Excellent written/oral communication and interpersonal skills.
Thorough approach and high attention to detail.
Strong time management and organisational skills.
Excellent computer skills including use of programs such as Microsoft Word.

BENEFITS:

Company pension
Free parking
Life insurance
Private dental insurance
Private medical insurance

TC BioPharm jobs

Production Manager