Technical Manager - Sterile Processing
- Provide technical and scientific leadership within OXB on aseptic processing and fill/finish activities for clinical and commercial manufacturing including technology transfer, technical troubleshooting, and continuous improvement of sterility assurance.
- Act as Subject Matter Expert (SME) utilising your technical competence and knowledge in aseptic processing, fill-finish, inspection and packaging to provide guidance on best practices to improve aseptic processes and procedures and maintain regulatory compliance
- Coordinate cross-functional root cause investigations as appropriate using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
- Generate and review documentation supporting technology transfer and New Product Introductions (NPI). Define appropriate success criteria for technical transfer and provide/document evaluation of the technical outcomes.
- Responsible for associated OXB documentation to ensure quality and compliance required for regulatory submissions
- Develop and maintain relationships with key suppliers and technology providers.
- Any other activities as required by the senior management team.
- Significant experience within of working in a GMP environment, Experience of working in multiple aseptic or sterile product manufacturing facilities would be ideal.
- Provide subject matter expertise (SME) within OXB on clean room technologies, single use systems and raw materials, design of process simulations (media fills), sterile manufacture, sterilisation processes, container integrity and particulate inspection, primary/secondary packaging, and basic microbiology.
- Extensive knowledge of the design, validation, operation and maintenance of the controlled environment including clean rooms, isolators, RABs, sterilisation processes, environmental monitoring and routine disinfection. Experience of manual and automated fill finish operations would be ideal.
- Experience in preparation for and participation in inspections (including FDA & MHRA) as well as performing focused GMP audits of sterile facilities.
- Experience in the design and use of single-use systems in sterile manufacturing would be ideal.
- Perform root-cause investigations using a systematic approach for process failures and corrective/preventative action plans.
- Experience of providing innovative solutions to solve complex problems in aseptic processing, and lead multidisciplinary teams in developing and implementing solutions.
- Provide input to regulatory submissions for in-house and client projects as required.
- Bachelor degree (Masters/PhD/EngD preferred) or equivalent experience in a relevant science (e.g. Biological Sciences, Microbiology,) with substantial relevant experience in an industrial setting
- At least several years’ experience of working in multiple aseptic or sterile manufacturing facilities
- Proven influencing skills at all levels of seniority
- Excellent communication skills (including verbal and written) able to interact cross-functionally at all levels.
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive; solution-oriented
- Leadership qualities
- A personal drive for keeping abreast of, and implementing scientific and technological advancements
Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
*no agencies please*