As our Technical Manager you will be our chosen subject matter process engineering expert for our new Fill/Finish function. Your key objective will be to manage all GMP aseptic processing support activities within the new facility, providing technical support to in-house and third party clinical and commercial sterile manufacturing activities.
* 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
* 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 * Significant experience working within GMP environment ideally within multiple aseptic or sterile product manufacturing facilities * 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. * Experience of providing innovative solutions to solve complex problems in aseptic processing, and lead multidisciplinary teams in developing and implementing solutions. * Proven influencing skills at all levels of seniority * Excellent communication skills (including verbal and written) able to interact cross-functionally at all levels * Proven capability of keeping abreast of, and implementing scientific and technological advancements
**We look forward to receiving your application.**