A leading diagnostics manufacturer has an exciting opportunity for a Manufacturing Supervisor to join its team. Your role will be to ensure that manufacturing processes are carried out safely and efficiently and to meet the needs of the production schedule. You will need to have proven experience working in a GMP manufacturing environment with additional knowledge of protein purification and cell culture techniques. It is also essential that you have experience in supervising and/or managing teams.
May include some or all of the following:
Manufacture products to meet our customer requirements by:
Working closely with the planning team and agreeing a suitable production plan
Making best use of available resources (people, plant & equipment)
- In conjunction with the Director of High Volume Production and the Technical Operations Group, develop and agree continuous improvements activities within 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
- 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 products, ensuring compliance with appropriate quality standards.
- The postholder is responsible for ensuring that the high standards of cleanliness and workplace organisation are adhered to at all times.
- Shared responsibilities for process variances including batch failures. This responsibility is shared with the Technical Operations Group.
- Attend training and to develop relevant knowledge and skills.
- Takes decisions based on protocols as well as their interpretation of departmental objectives and standards
- Work is supervised on the delivery of results
- Decisions impact own and other operational departments
- To have a good understanding of all the products and processes
- To maintain the above-mentioned quality standards.
- To be responsible for 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 team
- Prepare and manage the budget and forecasts to meet agreed business targets.
- Represent the Division/Company both internally and externally in a professional manner.
- To be familiar with and use all appropriate administrative systems and documentation applicable to the Facility.
- To provide as dictated by the needs of the business, an operations resource in other areas of work in and outside the Facility, in order to maximise the site flexibility and optimise efficiency.
- The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements
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
- Good understanding and experience of cGMP is essential
- Protein Purification
- Cell Culture Techniques
- Experience of working in clean room environments.
- Experience in supervision management
- Experience in Batch Manufacturing
- Skills / Pre-requisites
- Good interpersonal and leadership skills
- Strong person manager
- Flexible and able to work with changing priorities
- Ambitious and willing to take responsibility
- Ability to work within tight budgets and timelines
- Required to work independently and have the ability to plan and prioritise varying and high volumes of work.
- Required to work alongside other department members and other disciplines within the business when involved in or managing new project
- Good attention to detail.
- Problem Solving
- Enjoys new opportunities and challenges.
- Well organised, can plan and prioritise work.
- Works well under pressure in a constantly changing
Management, HS&E courses available.
Kaizen & LEAN /Six Sigma belt training.
Job Ref: 6695