Technical Manager - Sterile Processing (Fill/Finish), MSAT
- Experience Level
- Experienced (non-manager)
We are very proud to announce that our Manufacturing, Science and Technology are now hiring for our brand new Facility “Oxbox”.
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.
No agencies please.