Job description: We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. We are currently recruiting for (a) Director level MSAT professionals to join our newly established Global MSAT Team based from either our Oxford, UK, Strasbourg/Lyon, France or Cambridge, MA, US locations. The purpose of the role is to lead the implementation and maintenance of OXB’s analytical platforms and all analytical aspects of Client’s Programmes across the global network. The role will focus in areas of analytical harmonization, new technology introduction, continuous process improvement, and cross site analytical transfers, working closely with the site functional teams. It will also provide support for the analytical aspects of Client regulatory submissions, providing appropriate source documentation and performing reviews of the relevant sections of the regulatory documents. Your responsibilities in this role would be: Develop and oversee rollout and implementation of harmonization projects into the Global network sites, developing deployment plans cross functionally and supporting the on-site teams during all phases of transfer to meet business targets Lead on assigned global project implementation initiatives to sites and ensure all project timelines and objectives are consistently monitored and delivered Strengthen, standardise and drive consistency in execution across OXB’s global network, with tactical focus on the company’s varied complex activities and multi-vector strategy Develop and define OXB’s strategies for transfer of new analytical platforms & processes and new technologies and lead implementation with the site teams Oversee analytical technology transfers for early stage/late stage/commercial projects, including PPQ campaign support Provide technical leadership and know-how directly with cross functional teams across the OXB operations network and strengthen cross-site support and SME knowledge sharing Identify improvement projects to enhance capabilities and resolve current and future challenges on integrated continuous processes, analytical automation Responsible for ensuring analytical process network alignment through platform strategy documents and business process. Profile description: We are looking for: Degree in Science / Engineering or related technical discipline, or equivalent level of work experience Extensive knowledge and practical experience of technical areas relevant to viral vector CDMO technologies and commercialisation Proven proficiency in supporting regulatory submissions Significant industrial experience in industrialisation of GMP assays, technical support & process troubleshooting Recognised SME in a technical field of expertise covering areas such as technology transfer, analytical assays, and analytical validation Strong expertise in understanding, utilizing, and integrating various analytical techniques with the ability to assess and recommend the best tools and technologies for business needs Experienced project manager, with skills in developing staff and/or processes and managing resources, Excellent communication skills with the ability to work effectively and influence in diverse and interdisciplinary teams both internally and externally with customers. 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 commercialisation. 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 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.