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MSAT Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 27/04/2018
  • Job reference: J385539A

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MSAT Specialist

A MSAT Specialist is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for providing 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 a perfect opportunity to join a select team that has already established itself as a frontrunner 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 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/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

Skills/Competencies

  • Good communication/organisation/time management skills
  • Previous GLP experience in a regulated environment
  • Strong attention to detail with documentation/SOPs/CAPAs etc.
  • Strong Planning/Organising skills
  • Working knowledge of computer systems (Microsoft Office etc.)

Interested? Please get in touch with Jack to discuss further!

jack.conway-kenny at experis.ie or 01-6455262