Materials Science Technical Specialist

IrishJobs

Cork, Cork, Ireland

Cork, Cork, Ireland

Über

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.

TLNT1_IJ

Cork, Cork, Ireland

Sprachkenntnisse

English

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