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MSAT Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 20/07/2018
  • Job reference: BBBH15045

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MSAT Specialist

My Client, a leading multinational is currently seeking a MSAT Specialist to join their expanding team and provide technical support for internal and external technology transfer of bio pharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

  • Evaluate manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generate facility fit assessments and high-level gap assessments.
  • Generate and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate).
  • Generate options to resolve technical challenges and present them for endorsement.
  • As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the sites.
  • Gather, trend, and analyse process generated data; summarise findings in memos and reports and presentations.
  • Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.).
  • Participate in study teams and investigations (internal and external).
  • Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
  • Monitor and prioritise processes and troubleshoot technical difficulties as needed.
  • Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
  • Help to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identify continuous improvement activities to improve performance.
  • Travel may be required in support of tech transfer activities.

Education and Experience:

  • Manufacturing Sciences and Technology Specialist requires BS/BA in a scientific discipline or engineering with 3 years of related experience in a cGMP environment, or MS with 1 year experience;
  • Process development or production experience preferred

For more information on this and other positions please contact Kathryn on or call 016455250

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