CK Group are recruiting for a Manufacturing and Technology Transfer Manager on behalf of a growing biopharmaceutical organisation, to be based at their site in Abingdon on a permanent basis.
You will be responsible for providing management of GMP manufacturing operations and providing technical expertise in the technology transfer of new products from Process Development Teams into the GMP Manufacturing Suite, ensuring all transferred processes are suitable for Phase I and Phase II clinical trials.
Your duties will include:
o Management of the daily operation of the GMP manufacturing suite
o Development of process control strategies to assist in gaining regulatory approval of new products
o Providing technical expertise in the technology transfer from CMOs
o Continuously supporting the manufacture of vaccine products through the execution of technical lifecycle management programmes aimed at improving and optimising manufacturing processes.
o Sourcing materials, consumables and process equipment suitable for manufacturing vaccines for Phase I and Phase II clinical trials
o Ensuring all procedures meet the current GMP requirements
o Generating training plans, work-based training packages and training out all operators
o Ensuring that equipment is qualified and within calibration, servicing, and qualification dates at all times.
o Supporting regulatory submissions and regulatory inspections.
o Authoring documents including SOPs, Technology Transfer Plans, Technology Transfer Reports, Batch Manufacturing Records, Material specifications, Process Risk Assessments, FMEAs, Gap analysis and Technical Reports
To be considered for the position you should have the following skills and experience:
o Substantial experience of working in a relevant GMP manufacturing environment.
o Experience in the operation of bioreactor vessels
o Experience in Tangential Flow Filtration (TFF)
o Previous experience of transferring products
For more information, or to apply for the position, please contact Sarah Farrow on 0191 3706486 or firstname.lastname@example.org. Entitlement to work in the UK is essential for this role.