We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dunboyne. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
• Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes
• Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
• Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents
• Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual
• Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to “one-click” tech transfer
• Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
• Ensure the highest Quality, Compliance and Safety standards.

• Minimum of 5 years of work experience in the pharmaceutical or biotech industry
• Bachelor’s degree in: Biotechnology, Engineering, Chemistry, or related field.
• Experience with project management with cross-functional team members.
• Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing
• Competent in analyzing complex situations and showing practical problem-solving capabilities
• Experience with quality management and compliance systems.
• Understanding of the general principles of New Product Introduction (Tech Transfer)
• Familiarity with the use of Automation systems in a manufacturing Process.
• Competency in the use of automated/digital systems such as DeltaV, MES, eVal
• Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Validation experience including validation documentation generation and execution
• Familiarity with risk assessment processes