A leading diagnostic manufacturer requires an experienced manufacturing manager to lead its therapeutics division. Leading a team of 7, your role will be to ensure that manufacturing processes are carried out safely and efficiently to meet the needs of the production schedule. You must have significant experience leading a manufacturing team with working knowledge of protein purification processes.
- In conjunction with the Director of High Volume Production and the Technical Operations Group, develop and agree continuous improvements activities within the TMF according to the Monozukuri handbook.
- Facilitate cross training for the production technicians to minimise impact on the Manufacturing schedule when key staff are absent.
- Responsible for ensuring on-time completion of CAPA's and on-time close-out of Deviations assigned to the manufacturing area of the TMF.
- In conjunction with HS&E, ensure that all working systems under the control of the Production Team; are in compliance with safety, health and environmental requirements.
- In conjunction with QA, ensure all working systems under the control of the Production Team are in compliance with appropriate quality requirements.
- Responsible for batch record reviews for TMF products, ensuring compliance with appropriate quality standards.
- The postholder is responsible for ensuring that the high standards of cleanliness and workplace organisation within the TMF are adhered to at all times.
- Shared responsibilities for process variances within the TMF, including batch failures. This responsibility is shared with the Technical Operations Group.
- Takes decisions based on protocols as well as their interpretation of departmental objectives and standards
- To have a good understanding of all the products and processes within the TMF Facility.
- To be responsible for TMF staff maintaining complete, accurate and detailed records (in compliance with relevant regulations) to enable items to be readily traceable.
- To communicate at the earliest opportunity to QA and the Director of High Volume Production any events, actions or deviations which may impact cGMP compliance.
- Manage the training and development of all subordinates ensuring that training and development plans match the needs of both the business and the individual.
- Prepare and manage the TMF budget and forecasts to meet agreed business targets.
Education / Experience:
- Graduate in an appropriate scientific discipline and/or significant process experience within a highly technical and quality led business (biologics manufacture, diagnostic enzymes, pharmaceuticals, medical devices
- Good understanding of quality & HS&E requirements in an ISO regulated manufacturing environment
- Protein Purification
- Cell Culture Techniques
- Experience of working in clean room environments.
- Experience in supervision management and
- Experience in Batch
- Good understanding and experience of cGMP is critical.
Salary £40k - £55k
Job Ref: 5473