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Job Description
Job Summary: Lead new product introductions, Troubleshoot drug product processing technologies, Develop and characterizes drug product processes, and Ensure site meets quality requirements.
- Leads new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective.
- Troubleshoots issues with drug product processing technologies and equipment.
- Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
- Ensures all aspects of activity within any given process validation adheres to required policies and procedures.
Requirements:
- A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline.
- 5 years' experience in a similar role or Master's degree & 3 years of directly related experience.
- Experience in support of Commercial Protein Drug Product (DP) processing.
Key Skills:
- Applying fundamental engineering and scientific principles to process validation.
- Knowledge of protein biochemistry regarding chemical and physical stability.
Additional Information: Interested candidates should contact Seán McCarthy at +353 87 798 8480 or sean.mccarthy@lifescience.ie for further details.