Biological Manufacturing Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €80,000 - €120,000

We are seeking an experienced professional to join our team as a Upstream Technical Services Specialist. This role involves working closely with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure smooth technology transfer and routine manufacturing processes.

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  • Key responsibilities include media preparation, large-scale cell culture bulk drug substance manufacturing process.
  • The successful candidate will be responsible for authoring and reviewing process transfer documentation, gap assessments, technical protocols and reports.
  • Liaising closely with Global Process Development is crucial for overseeing the design and execution of laboratory studies.
  • This position requires supporting the introduction of new raw materials and consumables through the generation of materials lists.
  • Collaboration with colleagues is essential to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • The ideal candidate will have the ability to identify and implement process improvements, such as yield and cycle time reduction.

Requirements:

This role requires a minimum 5+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation.

  • A comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing is essential.
  • Techincal and operational knowledge of multiple unit operations in cell culture processing is also required.
  • Experience of Technology Transfer activities is highly desirable.

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