Cheltenham
Company description: OXB 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, OXB has more than 30 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 patients 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). 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 commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. Job description: Join Us in Changing Lives At OXB , our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful . Were currently recruiting for a MSAT Data Lead to join our Manufacturing and MSAT team . In this role, you willbe responsible for managing all data requests and statistical analysis activities that support the team, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Acting as the lead contact for MSAT data requests, ensuring data is accurate, accessible and compliant. Maintaining data integrity, traceability and governance across manufacturing, process and quality systems. Performing statistical analysis and process trending to support data-driven decision making. Generate data packages and reports for process validation, regulatory submissions, audits and client requests Providing data-driven insights to support investigations, root cause analysis and continuous improvement activities. Developing and maintaining dashboards, reporting tools and analytical models for MSAT and manufacturing teams. Collaborating with cross-functional stakeholders to improve data capture, reporting and system effectiveness Identifying and implementing opportunities for digitalisation, process optimisation and operational excellence. We are looking for: A degree in a relevant discipline A strong understanding of GMP principles, data integrity expectations, Continued Process Verification (CPV), and regulatory requirements for pharmaceutical manufacturing Working knowledge of MSAT activities including technology transfer, validation lifecycle and process optimisation Experience with statistical and data analysis tools such as Minitab, JMP, Power BI or similar About Us: OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy 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, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXBs world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines. OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US. Why Join Us? ??Competitive total reward packages ??Wellbeing programsthat support your mental and physical health ??Career development opportunitiesto help you grow and thrive ??Supportive, inclusive, and collaborative culture ??State-of-the-art labs and manufacturing facilities ?? A company that lives its values: Responsible, Responsive, Resilient, Respect We want you to feel inspired every day. At OXB, were future-focused and growing fast. We succeed togetherthrough passion, commitment, and teamwork. Ready to Make a Difference? 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 patients 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. TPBN1_UKTJ