- Experience Level
- Experienced (non-manager)
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 to join our Analytical Services Group. The purpose of this role is to support and assist ASG to ensure timely reporting of analytical data, effective management of stability programs and provide oversight of ASG compliance with internal and external GMP requirements
Key responsibilities and accountabilities:
- Over-see collation of data points from assay controls and product data to trend 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 study 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 records are progressed in agreed timelines and provide monthly departmental metrics
Key skills and requirements:
- Experience within a QC testing laboratory in a GMP regulated environment
- Good interpersonal and communication skills
- Delivery focused; strong organizational and time management skills
- Able to priorities workload and adapt to changing business needs
- Computer literate (Word, Excel, MS Office)
- Educated to BSc level in a relevant discipline
- Some experience working in a pharmaceutical regulated environment
No agencies please