PBL656 Unit Manager (Downstream Processing)
- Recruiter
- Porton Biopharma
- Location
- Salisbury
- Salary
- Competitive
- Posted
- 27 Jul 2021
- Closes
- 20 Aug 2021
- Sectors
- Manufacturing & Industrial
- Contract Type
- Permanent
- Hours
- Full Time
The successful candidate will be joining the Production Department, who are responsible for the purification of Drug Substance and the manufacture of buffer solutions. As a Unit Manager for Porton Biopharma, the post holder will manage all of the aspects of the production Units involved in this role.
*Key responsibilities*
* 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 ready at all times 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.
*Person Specification*
* Have current right to work in the UK;
* Someone with a degree in a biological sciences or relevant discipline, or significant relevant experience
* Experience working in a clean room environment including a management/supervisory role in GMP manufacturing environment
* Writing and reviewing batch documentation and SOPs
* Downstream processing experience
* Batch and facility planning to support schedules including monitoring, adjusting and ensuring compliance with schedules
*
* Experience of managing teams of technical staff
* Comprehensive understanding of critical utilities, calibration, Validation, and maintenance activity associated with a GMP environment
*Key responsibilities*
* 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 ready at all times 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.
*Person Specification*
* Have current right to work in the UK;
* Someone with a degree in a biological sciences or relevant discipline, or significant relevant experience
* Experience working in a clean room environment including a management/supervisory role in GMP manufacturing environment
* Writing and reviewing batch documentation and SOPs
* Downstream processing experience
* Batch and facility planning to support schedules including monitoring, adjusting and ensuring compliance with schedules
*
* Experience of managing teams of technical staff
* Comprehensive understanding of critical utilities, calibration, Validation, and maintenance activity associated with a GMP environment