Senior Manufacturing Projects Lead

Amgen SA; Dún Laoghaire; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Amgen Dun Laoghaire seeks a Senior Associate Manufacturing to partner with cross-functional teams on aseptic fills and process improvements. You will own manufacturing processes, drive CAPEx projects, and contribute to NPIs and lifecycle activities within a dynamic site.

You will ensure GMP compliance, develop documentation, and support training and protocol updates to enable efficient production in vial and syringe operations.

Qualifications

• Bachelor’s degree in a science discipline.
• 4+ years of biopharmaceutical manufacturing experience in Fill Finish or related GMP.
• Experience with regulatory compliance in cGMP manufacturing and testing.

Responsabilités

• Function as site interface between PDTs and ADL Manufacturing operations.
• Develop, review, and approve Master Batch Records and related documents.
• Lead change controls and review protocols for manufacturing activities.
• Coordinate NPIs, lifecycle/projects and CAPEx initiatives.
• Ensure GMP standards are maintained and training materials are updated.

Connaissances

Project management

Technical writing

GMP documentation

Problem solving

Cross-functional collaboration

Formation

Bachelor's degree in science

Description du poste

Amgen Dun Laoghaire seeks a Senior Associate Manufacturing to partner with cross-functional teams on aseptic fills and process improvements. You will own manufacturing processes, drive CAPEx projects, and contribute to NPIs and lifecycle activities within a dynamic site.

You will ensure GMP compliance, develop documentation, and support training and protocol updates to enable efficient production in vial and syringe operations.