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NIBSC has statutory responsibility for the standardisation and control of biological medicines including vaccines, blood products and other substances which cannot be characterised chemically and which require special testing measures to ensure their safety and efficacy.

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The Institute, a centre of the Health Protection Agency, is the major World Health Organization Laboratory for the production of International Standards for these products. It is also responsible for the quality testing of batches of these products for use in the UK and Europe. Scientists in the Institute are called upon to advise many bodies including the Department of Health, the MHRA (previously Medicines Control Agency) and the European Medicines Evaluation Agency and are involved in the work of the European Pharmacopoeia. The Institute is also active in research and development related to its statutory functions which amounts to about one third of its overall function.

 

The Institute’s lead biological Divisions are assembled into three Strategic Groups: Vaccines (Bacteriology, Virology and Retrovirology); Biotherapeutics (formerly Haematology, Immunology and Endocrinology); and Technology Development and Infrastructure (TDI) which comprises four departments (LMS, Cell Biology and Imaging, IT, Statistics), together with three additional smaller modules (Standardization R&D, Protein Molecular Biology, and the Information and Communication Centre (ICC). These Strategic Groups are supported by other groups such as Operations (including Standards Production and Dispatch), Finance, Human Resources and Quality.