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Unit Manager - Downstream Process

Posted 18/08/2021
£ Attractive
Porton
Full time


Unit Manager – Downstream Process

37.5 hours per week

Permanent

Porton

Salary Circa £29,355 - £43,000 per annum, dependant on experience

 

Company Information:

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



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