Quality Control Assay Development Specialist

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 26 June 2024 will be
considered. Please quote **172046** on all correspondence.