GMP Production Manager - 50K - Glasgow

Recruiter
Real Resourcing
Location
Scotland
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
GMP Production Manager

A superb opportunity to join an emerging cancer immunotherapy company developing cell based treatments. The role is based at their manufacturing facility in the central belt of Scotland.

The company is looking to recruit a highly motivated self-starting Production Manager with GMP manufacturing experience within the Biologics sector. The post holder will provide overall leadership to the production department and will report to the Vice President of Operations.

Key responsibilities will include -

* Oversee all commercial production operations, ensuring that suitable resources and expertise are employed to deliver the service in line with business objectives.
* Instil the necessary attitude and behaviours of all personnel in the department for the achievement of production efficiency and continuous improvement.
* In liaison with line management, to ensure that the necessary, resources, consumables, and facility, equipment and quality system GMP compliance is in place in time to meet the agreed project milestones. Where project milestones cannot be met, responsible for the communication of such instances to line management at the earliest possible opportunity.
* Ensure all manufacturing activities are undertaken in accordance with the registered product requirements and to current regulatory and quality standards.
* Ensure suitable metrics are applied to measure production resource utilisation and actual production costs. Conduct regular reviews of process efficiency and lead multifunctional teams as required to implement change management programmes as approved.
* Analyse all production methods, techniques, processes and machinery and develop and implement improvements or changes in order to maintain the highest levels of performance within the department.
* 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 our Quality Systems.
* Provide a high level of specialist technical and GMP production knowledge to deliver the technical transfer and validation of mammalian cell culture processes.
* Analyse, interpret and report production data and deviations to line manager, quality and project team. Present results in GMP compliant documentation, Milestone reports or at meetings to update project team or senior management.
* 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 and deviations, technical transfer documentation and project/client specific documentation.
* Manage the smooth technical transfer of new product manufacturing introductions into commercial operations and ensure that staff are suitably and fully trained in both the process technologies and key process parameters relevant to all new products.
* Manage members of the GMP Production Team, assign tasks, monitor performance on a frequent basis and support their personal development. Assist in development and setting of individual targets for the team and ensure that regular feedback is given
* Manage production activities including but not limited to, CAPEX equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, training records updated accordingly, ensuring equipment compliance and a clean, organised smooth production environment.
* 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.
* Assist in the preparation of department budgets and effective management of department costs.

The successful candidate will have -

Excellent attention to detail with a desire to continually develop and improve our processes.

The ability to work effectively within a small team.

Have demonstrable experience working within a GMP environment.

Have demonstrable experience within laboratory/GMP production materials control function.

Ability to learn and share your knowledge with the Quality Control team and production departments.

A determination to succeed with a "can do attitude".

The ability to work under pressure, working to deadlines and deliver results.

Flexibility and enthusiasm.

Excellent communication and interpersonal skills.

Exceptional organisational and time management skills.

Sthree UK is acting as an Employment Agency in relation to this vacancy.