MSAT Specialist – Limerick

  • Reference: GY46852
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

You will 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.

This is an opportunity to join a select team that is already leading the way in the Pharmaceutical/Biotech industry.

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.

 

 

Experience Education and Skills:

• 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 a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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