Upstream Technical Services Specialist – Pharmaceuticals - Dublin
Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for an Upstream Technical Services Specialist.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility.
Responsibilities:
1. Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
2. To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
3. To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies
4. To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
5. To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines
6. To identify and implement process improvements, e.g. yield, cycle time reduction
Required skills and experience:
7. Minimum 5+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation
8. Technical and operational knowledge of multiple unit operations in cell culture processing
9. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
10. Experience of Technology Transfer activities is advantageous
If this role is of interest, please apply now.
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