Materials Science Technical Specialist TPM6052

Summary:

A Materials Science Technical Specialist is required for a biopharmaceutical company in Cork. The successful candidate will provide technical expertise in biopharmaceutical manufacturing materials and processes, with a particular focus on single-use technologies including bags, filters, tubing assemblies and drug product materials. This role will support both commercial and clinical manufacturing operations by evaluating product-contacting materials, managing raw material changes, driving continuous improvement initiatives and supporting technology transfer activities within a cGMP manufacturing environment. The successful candidate will ensure manufacturing materials and processes meet quality, regulatory and operational requirements while supporting reliable product supply.

Responsibilities:

• Provide technical expertise on biopharmaceutical manufacturing materials, with a focus on single-use technologies.
• Lead and implement harmonisation, optimisation and continuous improvement initiatives relating to manufacturing materials and processes.
• Evaluate and approve raw materials for use within manufacturing operations.
• Assess supplier change notifications, material complaints and proposed raw material changes.
• Evaluate and test new manufacturing materials to determine suitability for production.
• Support technology transfer activities between Process Development and Manufacturing, ensuring alignment with established manufacturing practices.
• Manage raw material change requests, CAPAs and action items through the site's Quality Management System.
• Collaborate with cross-functional teams to support manufacturing operations, process improvements and strategic projects.
• Monitor project milestones and communicate project progress effectively to stakeholders.
• Prepare technical documentation, reports, spreadsheets and presentations using Microsoft Office.
• Maintain up-to-date knowledge of raw material technologies, regulatory expectations and industry best practices.
• Ensure all activities are performed in compliance with GMP and applicable quality and regulatory requirements.
• Other duties as assigned.

Qualifications & Experience:

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum of 3 years' experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences & Technology (MSAT), Process Development or a related technical function. Candidates with a Master's degree and at least 2 years' relevant experience will also be considered.
• Strong knowledge of pharmaceutical single-use technologies, including bags, filters, tubing assemblies, media, resins, chemicals and drug product materials.
• Good understanding of biopharmaceutical manufacturing processes including bioreactor operations, media and buffer preparation, filtration and related manufacturing technologies.
• Experience supporting technology transfer into clinical and/or commercial GMP manufacturing environments.
• Experience working within cGMP manufacturing operations and regulated pharmaceutical or biopharmaceutical environments.
• Knowledge of raw material standards and regulatory requirements, including USP and industry best practices.
• Experience working with Quality Management Systems, change control and CAPA processes.
• Proficiency in Microsoft Office applications, including Excel, PowerPoint and Project.
• Experience working with raw material suppliers and supplier management activities would be an advantage.