Operations Lead, Biotech Manufacturing & Projects

Amgen; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Associate Manufacturing to collaborate across Quality Assurance, Quality Control, Engineering, Facilities, and Process Development on aseptic drug product manufacturing. The role emphasizes New Product Introduction, lifecycle projects, and CAPEx initiatives within a fast-paced manufacturing environment.

The position requires a strong technical background in aseptic filling, lyophilisation, and capping, with a track record in process improvement and

Qualifications

• Bachelor's degree in science is required.
• 4+ years of biopharmaceutical manufacturing experience in Fill Finish or related GMP manufacturing.
• Experience with regulatory compliance is expected.

Responsibilities

• Serve as the operations lead for New Product Introduction, Life Cycle Management, and CAPEx projects.
• Coordinate manufacturing efforts across Formulation, Filling, and Inspection.
• Develop, review and approve Master Batch Records and Parameter Value Lists.
• Provide training and troubleshooting to ensure streamlined manufacturing operations.
• Collaborate with QA to maintain GMP standards and SOP compliance.
• Lead change controls and review Bills of Materials and risk assessments.

Skills

Biopharmaceutical manufacturing

GMP knowledge

Process improvement

Education

Bachelor's degree in a science discipline

Job description

Amgen Dun Laoghaire is seeking a Senior Associate Manufacturing to collaborate across Quality Assurance, Quality Control, Engineering, Facilities, and Process Development on aseptic drug product manufacturing. The role emphasizes New Product Introduction, lifecycle projects, and CAPEx initiatives within a fast-paced manufacturing environment.

The position requires a strong technical background in aseptic filling, lyophilisation, and capping, with a track record in process improvement and