Unit Manager – Downstream Process
37.5 hours per week
Salary Circa £29,355 - £43,000 per annum, dependant on experience
Porton is a medium sized life-science company performing a range development and manufacturing roles for biopharmaceuticals. This also includes all associated support functions from logistics through to engineering, quality control / quality assurance, regulatory affairs, and management. The Company manufactures two licensed products, Erwinase® and the UK’s Anthrax Vaccine as well as providing R&D services for product development.
Purpose of Role:
To lead the production team and provide production expertise and guidance to the group responsible for the delivery of production activities.
Main Responsibilities: (Not limited to):
- Implement and utilise a range of production methods and procedures in support of all activities associated with manufacturing.
- To ensure the facilities are maintained and fit for purpose.
- Ensure all support activities including Engineering and Validation, required to ensure GMP compliance are scheduled and executed.
- Supervision and training of staff
- Responsible for the generation of Non-Conformances, CAPAs, Risk Assessments and Change Controls
- Ensure the unit is always ready for audit by any regulatory organisation
- Responsible for the provision of all consumables and, supplies required for day-to-day activity.
- Identify, evaluate, and adapt new technologies where appropriate and ensure that the production area operates to a high standard and complies with GMP and other regulatory standards.
- Provide reports on all aspects of manufacturing as requested.To perform any other duties as per instructions of line manager/senior management.
Essential Person Specification:
- Have current right to work in the UK;
- Have a good standard of written and spoken English
- Degree in Biological sciences or relevant discipline or significant relevant experience
- Previous Mgmt / TL experience in a GMP manufacturing environment
- Preparation of batch documentation and SOPs
- Downstream Processing Experience
- Comprehensive understanding of critical utilities, calibration, validation, and maintenance activity associated with a GMP environment
- Ability to multitask
- Able to work on own initiative
- Work to deadlines