Page 1 of 2 Scientist for Analytical Development Group Oxford, Oxfordshire Salary competitive Permanent Profile of Role Oxford BioMedica’s Analytical Development group is seeking to expand and strengthen its team by recruiting an experienced scientist to support the development of an increasing portfolio of cell and gene therapies. The group is responsible for assay development and subsequent validation to support the GMP manufacturing process and early phase development. The role requires the ability to work in a multi-disciplined innovative environment whilst also adhering to internal and external quality systems. The Analytical Development Group works closely with research, manufacturing and clinical at all stages of development. A highly motivated and independent individual is sought to work within this team. The successful candidate will be expected to: ─ Perform investigational work, pre-validation and qualification of new and existing assays for research purposes and for application to ongoing regulatory studies (GxP) ─ Investigate and develop assays and technologies for qualitative and quantitative evaluation of lentiviral vectors ─ Prepare and review Standard Operating Procedures (SOPs) and associated documentation ─ Perform the role of project manager for validation studies with the responsibility for planning and execution of study procedures, and reporting of study results Skills/Knowledge/Qualifications ─ Min. BSc Degree in Life Sciences/Science/Analytical Science ─ A good R&D background in quantitative PCR and/or protein analysis ─ Practical industry experience in analytics and development projects/activities ─ Good level of communication and presentation skills Key Tasks ─ Innovation and development of new analytical assays ─ Validate and qualify assays for the purpose of GxP testing ─ Improvement and optimisation of current analytical assays ─ Drafting and preparation of standard operating procedures and associated paper work ─ Act as project manager for validation and qualification studies ─ Troubleshoot related assay performance issues as and when required ─ Training members of the Product and Release Testing Group (PARG) to perform newly developed and validated assays ─ Assist with other activities undertaken in the research group as required Competencies ─ A strong background in analytical assay development. A strong interest in manufacture of biopharmaceuticals and/or experience of working with lentiviral vectors would be an advantage ─ Good practical competence and technical understanding of bio therapeutic manufacturing and release testing ─ Demonstrated ability to work independently as well as in a team Page 2 of 2 ─ ─ ─ Ability to undertake projects to agreed timelines and adapt to rapid changes in project priorities Good written and verbal communication skills The ability to train others in the conduct of analytical techniques Desirable Skills ─ Industrial experience in developing assays to the level of current Good Manufacturing Practice would be advantageous ─ Previous experience with assay validation in an industrial setting ─ Experience in the design of multifactorial experiments ─ Use of statistics as applied to assay validation ─ Previous knowledge of the design and biology of Lentiviral vectors The successful candidate will report to the Team Leader for Analytical Development. Please use the cover letter to highlight how you meet the competencies for the role and to state your salary requirements and current salary. Your cover letter will be used along with your CV to assess your application. With your application could you please quote job reference OXBADG1