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Oxford BioMedica Limited
,
Oxford, Oxfordshire
Senior MSAT Scientist, Fill Finish
Overview
New opportunities to help us deliver innovation at our new state of the art fill/finish facility Our new fill/finish suites will contain bespoke-designed isolation technologies, automated filling systems and sanitisation technologies to meet the demanding process requirements of our viral vector products. We are seeking qualified Scientists/Engineers to provide the technical expertise to Oxford Biomedica and our third party Contracts Manufacturing Organisations (CMO) sites including technology transfer, new product introduction, process troubleshooting, deviation investigations, change control, and continuous improvement. Key Duties & Responsibilities : Actively participate in defining technical strategy for MSAT projects Generate and review documentation supporting technology transfer and New Product Introduction (NPI). Define success criteria for technical transfer and provide expert evaluation of the technical outcomes. Identify and lead continuous improvement opportunities relating to the manufacturing process. Lead root cause investigations using a systematic approach to resolve complex problems and implementing solutions. Writing of complex technical reports to a high standard Gather, evaluate and analyse process data for manufacturing process robustness. Develop relationships with new suppliers and service providers May Suggest changes to MSAT in lines with Regulations and guidance documents and execute the updates linked to this change Person Specification: Post-graduate degree in Biology/Biochemistry, Chemical/Biochemical Engineering or a related field. Process development or GMP production experience required. To Specialist experience in technology transfer and/or new product introduction within sterile fill finish environment essential. Expertise in the use / application of variety of problem solving tools and quality risk assessment methodologies would be ideal. Understanding of theoretical and practical challenges of scale-up would be beneficial. We look forward to receiving your application No agencies please