Materials Science Technical Specialist TPM6052

Tandem Project Management Ltd.

Cork

Hybrid

EUR 65,000 - 90,000

Full time

6 days ago
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Job summary

Tandem Project Management Ltd. in Cork seeks a Materials Science Technical Specialist to provide technical expertise in biopharmaceutical manufacturing materials and processes, with a focus on single-use technologies such as bags, filters, tubing assemblies and drug product materials.

The role supports commercial and clinical manufacturing by evaluating materials, managing raw material changes, driving continuous improvement, and supporting technology transfer within a cGMP environment to ensure

Qualifications

  • Bachelor's degree in Life Sciences or related field.
  • Master's degree with 2+ years of relevant experience considered.

Responsibilities

  • Provide technical expertise on biopharmaceutical manufacturing materials, focusing on single-use technologies.
  • Lead harmonisation, optimisation and continuous improvement of manufacturing materials and processes.
  • Evaluate and approve raw materials for manufacturing operations.
  • Assess supplier change notifications and material changes.
  • Support technology transfer between Process Development and Manufacturing in a cGMP environment.
  • Ensure compliance with GMP and regulatory requirements.

Skills

Single-use tech
Materials science
MSAT

Education

Bachelor's degree Life Sciences
Master's degree Life Sciences

Tools

Excel
PowerPoint
Project

Job description

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.
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