MSAT Specialist – Limerick | Collins McNicholas

MSAT Specialist – Limerick

  • Reference: GY45219
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

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

As MSAT Specialist you will supply technical support for internal & external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

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.

Skills, Experience and Qualifications:

  • 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

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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