Quality Control Assay Development Specialist

at  University of Oxford

We are seeking to appoint a Quality Control Assay Development Specialist to join our team at the Clinical BioManufacturing Facility (CBF) in the Nuffield Department of Medicine, to assist us in our mission to improve global health.
The Clinical BioManufacturing Facility (CBF) is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility, where basic research can be translated into Investigational Medicinal Products (IMPs) for use in clinical trials. The CBF produces high-quality Investigational Medicinal Products (IMPs) according to the requirements of Good Manufacturing Practice (GMP) to support early-phase clinical trials in the UK and worldwide. We manufactured the first doses of the Oxford AstraZeneca vaccine against Covid-19 for the UK trials and vaccines for Malaria, TB, Zika, Rabies, Plague, Ebola and other diseases that have a global impact.
You will have a hands-on role in the development and adoption of analytical techniques for new IMP projects coming into the CBF, and for modernising our existing QC testing portfolio. You will be working with external clients and the CBF’s Pre-GMP and QC teams to transfer analytical assays to the CBF and with the development and use of new assays at the technology transfer stage, ensuring compliance with appropriate regulations such as the European Pharmacopoeia (Ph. Eur.). You will liaise with and guide potential clients at early stages of manufacturing process development to ensure product assays are suitable for eventual GMP compliant use. In addition, you will write appropriate Reports, Risk Assessments and Standard Operating Procedures to enable the implementation of improved and new analytical assays.
It is essential that you hold a degree in a relevant biological/biomedical subject. You will be technically adept and experienced at laboratory techniques and assays including standard molecular biology techniques, and you will have experience in assay development. Additionally, you will be able to analyse and present scientific data, liaise with other scientists, write up and present research proposals and results, and represent the QC group at meetings, internally and with external clients. Experience of working in a GMP environment would be highly desirable.
Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience.
This position is offered full time on a fixed term contract for 3 years and is funded by the Department.
Only applications received before 12 midday on 2 May 2024 will be considered. Please quote 172046 on all correspondence

Please refer the Job description for details