Analytical Method Transfer Specialist

3 days ago

Co Meath, Ireland beBeeLaboratory Full time €90,000 - €110,000
Job Overview

We are seeking an experienced QC Laboratory Manager to lead a team responsible for overseeing the technical transfer of In-Process Control (IPC) analytical methods and testing.

  • Lead planning and execution of analytical method transfers, ensuring adherence to project timelines and objectives.
  • Serve as primary point of contact for IPC technical transfer activities, liaising between internal analytical teams, manufacturing sites, and external partners.
  • Coordinate development and validation of IPC analytical methods, including protocol design, execution, and documentation.
  • Conduct risk assessments and troubleshooting activities to address IPC technical challenges and ensure successful implementation of analytical methods.
  • Generate and review technical documents, including IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.
Requirements
  • Bachelor's degree or equivalent in Biological Sciences, Chemistry, or other biotechnical science or equivalent experience in a regulated industry.
  • Minimum of 10 years of laboratory experience in a GMP laboratory environment.
  • 5 years of analytical instrument validation/qualification experience preferable.
  • Proven leadership of laboratory staff and experience in a GMP laboratory.
  • Proven ability to work in a matrixed organization.
  • In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.
What We Offer
  • Opportunity to lead a team and drive continuous improvement initiatives.
  • Chance to work with a leading pharmaceutical client in Dublin.

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