Job Description
The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at our facility in Blanchardstown, Dublin. The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability Skills: Drug Substance Process Development Supply Chain Management Operations Process Validation