A pharmaceutical company based in Limerick is currently recruiting for a MSAT Specialist to join their team. This is a permanent, full-time position offering a fantastic salary and the opportunity to join an industry leading team.

Summary: Provide technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

Essential Duties and Responsibilities :

• Assess 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 analyze process generated data; summarize 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 prioritize 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.

• 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