Materials Management Scientist

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 break through medicines. This is a fully site based role on a brand new technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.

The Materials Management Scientist will provide technicaloversight 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 impact of supplier changes (drawing input from affected flow(s) scientific SMEs)
• Develop robust control strategies to manage supplier/material risk.

• Lead and/or coordinate materials investigations and changes.

• 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.