Technology Transfer Specialist

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

1. Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
2. Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
3. Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
4. Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
5. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
6. Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
7. 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.
8. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
9. Excellent troubleshooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.

Education & Experience

1. Minimum of 3 years of work experience in the pharmaceutical or biotech industry.
2. Bachelor’s degree in Engineering, Biotechnology, Chemistry, or related field.
3. Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
4. Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer.
5. 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.
6. Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.

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