Manufacturing Specialist
Brightwater
Limerick
One of the most dynamic and exciting manufacturing sites in Munster is seeking to add a number of MSAT Specialists to its high performing team and support Internal and External Tech transfer projects. If you`re passionate about science and relish the opportunity to work in a demanding but rewarding environment then this could be the next great step in your career. There are open roles at all levels from Associate Specialist to Senior Specialist. In this role 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. About the Job: 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. May involve supervision of lower level specialists. About You: Minimum of BS/BA in a scientific discipline or engineering. Associate Level requires 1 year of relevant experience. Specialist Level requires 2-3 years of relevant experience. Senior Specialist level requires 5 years of relevant experience. Bio pharmaceutical process development, manufacturing or process engineering experience a plus. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
1844 days ago