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Upstream Technical Services Specialist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
04-07-2024
32015
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:
  • 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.
  • To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
  • 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
  • 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
  • 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
  • To identify and implement process improvements, e.g. yield, cycle time reduction

Required skills and experience:
  • Minimum 5+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation
  • Technical and operational knowledge of multiple unit operations in cell culture processing
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
  • Experience of Technology Transfer activities is advantageous

If this role is of interest, please apply now.

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