Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market
Our recent successes are driving significant growth. As such, we are looking for a QC Officer within our Analytical Services Group. ASG primary focus is to perform in-process, QC release and stability testing for our partners. ASG operate to GMP performing safety, characterisation and residual testing assays. Technologies used include qPCR, HPLC, spectrophotometry and UV/fluorescence plate readers
Within this role your responsibilities will include ensuring timely reporting of analytical data, effective management of stability programs and provide oversight of ASG compliance with internal and external GMP requirements. You will oversee collation of data points from assay controls and product data to trending results, capture metrics leading to assay improvement and optimisation; maintain QC databases, Certificates of Analysis and Product Specifications; Prepare assay performance reports and product reviews; Ensure stability studies are set up, performed within the time point window and reported in a timely manner; Issue test samples and control materials, prepare outgoing shipments and receive incoming shipments; Review of contract testing organization protocols and reports; Ensure departmental quality records (CAPA, Deviation, Change Controls) are progressed in agreed timelines and provide monthly departmental metrics
To succeed, you will have experience within a QC testing laboratory in a GMP regulated environment, with good interpersonal and communication skills. You will be delivery focused, have strong organizational and time management skills. You will also be able to prioritise workload and adapt to changing business needs.
No agencies please