Validation Manager at University of Sheffield

Faculty: Faculty of Medicine Dentistry and Health

Contract Type: Fixed-term for 3 years

The Gene Therapy Innovation & Manufacturing Centre (GTIMC) Gene therapy is a promising treatment option for a number of diseases that currently have no other cures.

The GTIMC at Sheffield is one of three cutting-edge hubs in the UK dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases.

The Sheffield Hub, which is the first in the north of England, is part of an £18 million network created by LifeArc and the Medical Research Council (MRC), with support from the Biotechnology and Biological Sciences Research Council (BBSRC).

The GTIMC is located at the University of Sheffield’s Innovation District, close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

The centre will include a cutting-edge GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. In this way, it will play its part in increasing the number of treatments available for genetic diseases that currently have no cure.

Role Description

The post holder will collaborate with cross-functional teams, to support the successful launch and ongoing production within GTIMC. They will be responsible for ensuring that the GTIMC processes, equipment, and systems meet regulatory requirements and quality standards. The primary role is to validate and qualify manufacturing, QC and R&D processes and equipment to ensure that they consistently produce safe and effective products. Furthermore, the Validation Manager will be responsible for developing and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, to ensure that equipment and systems meet predetermined specifications.

The University We’re one of the best not-for-profit organisations to work for in the UK. The University’s Total Reward Package includes a competitive salary, a generous Pension Scheme and annual leave entitlement, as well as access to a range of learning and development courses to support your personal and professional development.

To find out what makes the University of Sheffield a remarkable place to work, watch this short film: www.youtube.com/watch?v=7LblLk18zmo, and follow @sheffielduni and @ShefUniJobs on Twitter for more information.

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