Oxford BioMedica (UK) Limited

Technical Manager - Sterile Processing (Fill/Finish), MSAT

Location
Oxford
Salary
Competitive salary
Posted
05 Aug 2019
Closes
04 Sep 2019
Ref
OXB- MSAT-1869
Discipline
R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
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”.

http://www.oxb.com/news-media/press-release/oxford-biomedica-announces-further-capacity-expansion-new-facility

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.

 Key responsibilities:

  • 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

Key requirements:

  • 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.

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