Senior Qualified Person
University of Oxford
Nuffield Department of Medicine, Jenner Institute
Clinical Biomanufacturing Facility, Old Road, Headington, Oxford OX3 7JT
Grade 10: £55,750 – £64,605 (with a discretionary range to £70,579 per annum)
Applications are invited for a Senior Qualified Person to join the Clinical Biomanufacturing Facility at the Jenner Institute, led by Associate Professor, Catherine Green.
We are looking for an experienced and motivated eligible QP, prepared to rise to the challenges of delivering novel innovative medicinal products to first in human trials for the University of Oxford, and other sponsors.
The CBF was at the forefront of delivering the Oxford/AstraZeneca vaccine against Covid-19 in record time, and our QPs worked closely with the trials teams, MHRA, CMOs, AstraZeneca and other stakeholders in this project, ensuring quality was maintained throughout. Previously the CBF was also instrumental in the rapid delivery of Ebola vaccines to UK trials, and we have manufactured imported and released a broad portfolio of IMPs to trials in the UK and globally over the past 20 years. The CBF is looking forward to continuing to support a broad range of vaccine and other biologics manufacturing, with plans for expansion and diversification in the short- to medium term.
You will join our close knit, experienced and passionate team, to make a truly significant contribution in the fight against disease with global impact. Due to the diverse nature of working in an academic environment the role will cover an exceptionally broad range of responsibilities, and so will suit a candidate willing to think creatively and to acquire new knowledge while in post.
You will be eligible to be a Qualified Person who can be named on the CBF’s MIA (IMP) with an experience in the manufacture of biological, sterile medicinal products, with proven experience in managing all aspects of Quality Assurance within a GMP regulated environment; experience of leading qualification/validation of assays, manufacturing process and equipment and facilities. You will also have sound knowledge of EU GMP guidelines (EudraLex Volume 4) and evidenced ability to interpret these for early-phase IMPs and ATMPs.
The post is fixed-term for 5 years, in the first instance and funded by the Department.
Applications for this vacancy are to be made online here
You will be required to upload a CV and supporting statement as part of your online application, potential applicants are encouraged to make informal enquires to the Head of Facility: Professor Catherine Green (firstname.lastname@example.org), for further details.
Only applications received before midday on Monday 22 March 2021 can be considered. Please quote reference 149423 on all correspondence.