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 identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
2. Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes
3. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
4. Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents
5. Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual
6. 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
7. Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
8. Ensure the highest Quality, Compliance and Safety standards.
Education & Experience
9. Minimum of 5 years of work experience in the pharmaceutical or biotech industry
10. Bachelor's degree in: Biotechnology, Engineering, Chemistry, or related field.
11. Experience with project management with cross-functional team members.
12. Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing
13. Competent in analyzing complex situations and showing practical problem-solving capabilities
14. Experience with quality management and compliance systems.
15. Understanding of the general principles of New Product Introduction (Tech Transfer)
16. Familiarity with the use of Automation systems in a manufacturing Process.
17. Competency in the use of automated/digital systems such as DeltaV, MES, eVal
18. Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
19. Validation experience including validation documentation generation and execution
20. Familiarity with risk assessment processes
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.