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Biopharmaceutical Process Expert
1 week ago
The role of a Technical Services Specialist involves supporting the cGMP manufacture of biological bulk drug substance (BDS) at our Dublin facility. This position is responsible for providing processing expertise to support technology transfer, process validation, and routine commercial manufacturing for Downstream manufacturing.
Key responsibilities include providing process expertise in Downstream purification processes, including buffer preparation, purification, and viral reduction steps, as well as DS formulation and bulk fill. Additionally, the Technical Specialist will author and review process technical documentation, gap assessments, technical protocols, and reports, and process validation documentation.
This role requires 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 startup and process qualification. The Technical Specialist will be accountable for timely completion of commercial sustaining and technical transfer related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Continued Process Verification (CPV), Risk Assessment (using QRM tools), and supporting technical and manufacturing deviations.
