- 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.
• 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: email@example.com