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Qualified Person

University of Oxford - Nuffield Department of Medicine (NDM), Clinical BioManufacturing Facility

Location: Oxford
Salary: £47,263 to £54,765 per annum
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 17th April 2019
Closes: 3rd June 2019
Job Ref: 139770

Nuffield Department of Medicine (NDM), Clinical BioManufacturing Facility, Churchill Hospital, Headington, Oxford

Grade 9: £47,263 - £54,765 p.a.

A unique and exciting Qualified Person (QP) role is available at the Clinical BioManufacturing Facility (CBF) in Oxford. The CBF is part of the Jenner Institute (Nuffield Department of Medicine, University of Oxford) and has the busiest pipeline of any academic GMP facility in the UK for Phase I/II clinical trials. Recent CBF activities have included the production of innovative recombinant protein, adenovirus vectored, and VLP vaccines against pathogens which cause major global diseases such as malaria, Chikungunya, and Zika. We are also working in close collaboration with scientists at the Jenner Institute and major funding bodies to develop vaccines against emerging pathogens for future epidemic preparedness.

The main responsibilities of the QP role will be to certify externally manufactured and in-house production batches of investigational medicinal products (IMPs) for GMP compliance, and to provide QP certification for clinical release to trials both in Europe and worldwide. As many of the products and processes developed at the CBF are novel, the role will involve close interaction with the Sponsor and, where formal regulatory support is required, also with the MHRA. For externally manufactured products, QP oversight will be required including auditing activities.

The ideal candidate will be eligible to act as a QP in the UK and have experience in the manufacture of sterile investigational medicinal products (IMPs).  They will be expected to have a strong scientific and/or technical background and an in-depth knowledge of EU directives, regulations and guidelines. They are also expected to be experienced in Quality Management Systems, performing reviews of GMP records, performing and hosting audits and leading or providing support for critical activities including deviations, out of specification investigations, complaints and recalls.

This is an opportunity to join a team working at the cutting edge of vaccine development in a unique academic setting. We are therefore looking for a motivated team player able to rise to the challenges of working with previously untested innovative products.

This post is offered on a full-time, fixed-term basis until 31 July 2021 in the first instance.

All applicants must complete a short application form and upload a CV and supporting statement.

Only applications received before 12.00 noon on Monday 3 June 2019 will be considered.

https://www.recruit.ox.ac.uk/pls/hrisliverecruit/erq_jobspec_version_4.jobspec?p_id=139770 

   
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