ASG QC Officer

Job description: We pride ourselves on our integrity. We do what’s right for our employees, patients and partners, and so can you. We are currently recruiting for an ASG QC Officer to join the Analytical Services Group (ASG) team. The purpose of this role is to ensure timely reporting of analytical data, provide oversight of ASG compliance, manage stability programs, and continuously improve ASG processes in line with GxP requirements. Our Analytical Services Group supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics. Your responsibilities in this role would be: Writing and reviewing SOPs and documentation related to QCO activities Assisting with troubleshooting QCO-related issues Coordinating stability studies and ensuring timely QC checks of stability reports QC checking of submission forms for external testing, reports, and data in COA/COT Coordinating and arranging outgoing shipments to external testing facilities Tracking and monitoring departmental quality records and reporting metrics Training team members in multiple processes/procedures Managing and overseeing QCO processes Providing analytical and stability updates to internal and external customers Inputting into the validation of analytical spreadsheets Generating and issuing stability plans, protocols, and reports at each time point Performing trend analysis of assay controls and standards Creating, managing, and QC checking stability trackers Generating batch-specific COA and COT and maintaining the QC database Updating product specifications and reporting data to customers Performing calculation checks for QC release assays Generating monthly metrics for the Head of Department Managing departmental quality records and liaising with external testing labs We are looking for: Science graduate with a biological background or experience working within a pharmaceutical regulated environment Knowledge of QC testing within a GMP environment Computer literacy (Word, Excel, MS Office) Detailed understanding and ability to uphold/improve GMP compliance for ASG processes and procedures Ability to communicate effectively both internally and externally Strong problem-solving skills and ability to make informed decisions Excellent time management and organizational skills Ability to work independently and as part of a team Highly motivated with excellent attention to detail About Us: OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialization. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. What’s in it for you: Highly competitive total reward packages Wellbeing programmes Development opportunities Welcoming, friendly, supportive colleagues A diverse and inclusive working environment Our values are: Responsible, Responsive, Resilient, Respect State-of-the-art laboratory and manufacturing facilities We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you. Collaborate. Contribute. Change lives. LI-SCM1 We offer: Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy). Oxford Biomedica collaborates with some of the world\’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica\’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.