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 execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
• Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
• Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
• Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
• Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
• Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
• Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.

• Minimum of 3 years of work experience in the pharmaceutical or biotech industry
• Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.
• Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
• Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer
• Familiarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.
• Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.