A Materials Management Scientist/Snr Scientist - Technical Services/Manufacturing Sciences is required to join a leading global Biopharmaceutical business based in Limerick. This is a fantastic opportunity to join a global business focused on developing and manufacturing breakthrough medicines. This is a fully site-based role on a brand new state-of-the-art manufacturing site.
The Materials Management Scientist will provide technical oversight of raw materials and consumables to ensure the reliable supply of material with safety first and quality always. Scope of work includes qualification, implementation, continuous improvement, investigation support, and technology transfer. This position will interact with Engineering, Operations, Quality Assurance, Quality Control, Procurement, and Regulatory departments in Limerick and globally, as well as with external suppliers.
The Role
* Understand the scientific principles required for manufacturing intermediates and bulk drug substances, especially as concerns the impact of material attributes on process chemistry & product protection.
* Serve as scientific liaison between the Materials/Procurement Process Team and Process Scientist.
* Establish and own the site’s extractables and leachables program to create documented risk assessments to enable manufacturing start.
* Work with the Materials/Procurement Process Team to: Assess materials & supplier risk, Audit suppliers, Assess & address the impact of supplier changes (drawing input from affected flow(s) scientific SMEs), and Develop robust control strategies to manage supplier/material risk.
* Lead and/or coordinate materials investigations and changes.
The Person
* Hons Degree Qualified BSc, MSc, or PhD degree based in biotechnology, biochemistry, chemistry, or similar discipline.
* Over 5 years’ experience working in a GMP or GLP manufacturing environment and with external vendors.
* Knowledge of cell culture, purification, and the support systems used in the manufacture of biotech products is required.
For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie
Seniority level
Associate
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
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