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. Responsible for the participation in and leading of key technology transfers activities, in support of clinical and commercial new product introduction projects.
2. Development of strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
3. Acting as process Subject Matter Expert in the support of process investigations.
4. Use of risk management techniques to assess strategies, prioritize activities and initiatives.
5. Lead other significant business critical projects on site associated with new product introduction and site capability build.
6. Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.
7. Ongoing optimization of process equipment and development of future breakthrough business solutions.
Education & Experience
1. Experience in a biologics drug substance environment.
2. Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
3. Experience in technology transfers for clinical or commercial biologics strongly desired.
4. Experience with automated systems highly desired.
5. Process validation and cleaning validation experience desired.
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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