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 Thursday 1 August 2019 will be considered.
Contact: Phillippa Wall (01865 617971)
Nuffield Department of Medicine (NDM), Jenner Institute, Clinical BioManufacturing Facility, Old Road, Headington, Oxford
Grade 7: £32,236 - £39,609 p.a.
We are currently seeking an experienced GMP (Good Manufacturing Practice) Production Manager. The postholder will be a member of the Clinical BioManufacturing Facility’s Production team working in our regulated cleanrooms to produce Investigational Medicinal Products (IMPs) for clinical trials.
You will have operational responsibility for the manufacture and storage of IMPs, including adenoviral-vectored vaccines and Advanced Therapy Medicinal Products, ensuring compliance to the principles of GMP throughout.
You will provide line management to a small production team and assist with the manufacturing processes and cleanroom activities as required, whilst ensuring adherence to defined manufacturing timelines.
You will be educated to BSc degree level (or equivalent) in a relevant subject and have relevant post-graduation experience, from a similar role. Experience in cleanroom working according to GMP, virus culture and biological downstream processing techniques are preferred. We are looking for someone who is highly organised and motivated with good interpersonal skills. Excellent communication, planning and prioritising skills and the ability to work both as part of a team and independently are essential.
Applications for this vacancy are to be made online and you will be required to upload a supporting statement as part of your online application.
This position is full-time, on a fixed-term contract for 2 years and is funded by the Department.
Only applications received before 12.00 noon on 25 July 2019 will be considered.
Contact: Phillippa Wall (01865 617971)