Aseptic Manufacturing Projects Lead – Onsite Dublin

Amgen; Dublin; Hybrid; EUR 56,000 - 76,000; Full time

Job summary

Amgen in Dublin, Ireland, is seeking a Senior Associate Manufacturing to join the Dun Laoghaire site on-site. You will partner across QA, QC, Engineering, Facilities and PD to drive NPIs, lifecycle projects and process improvements in aseptic drug product manufacturing.

The role requires a science degree and 4+ years in biopharma manufacturing, with proven cGMP experience, strong project management, and ability to lead change controls, write GMP documentation, and deliver right-first-time

Qualifications

• Bachelor’s degree in a science discipline.
• 4+ years of biopharmaceutical manufacturing experience (Fill Finish).
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Strong project management and organisational skills, including ability to follow assignments through to completion.
• Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
• Demonstrated ability to work independently and deliver right first-time results under minimal direction

Responsibilities

• Coordinate manufacturing activities for NPIs, lifecycle and CAPEx projects.
• Develop and approve Master Batch Records and parameter lists across Formulation, Filling and Inspection.
• Support scheduling and execution of Characterisation, Engineering and PPQ runs.
• Provide troubleshooting support on the floor during project execution.
• Partner with QA to maintain GMP standards and review documentation.
• Lead change controls and review Bills of Materials.

Skills

Project management

GMP compliance

Technical writing

Operations leadership

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in a science discipline

Job description

Amgen in Dublin, Ireland, is seeking a Senior Associate Manufacturing to join the Dun Laoghaire site on-site. You will partner across QA, QC, Engineering, Facilities and PD to drive NPIs, lifecycle projects and process improvements in aseptic drug product manufacturing.

The role requires a science degree and 4+ years in biopharma manufacturing, with proven cGMP experience, strong project management, and ability to lead change controls, write GMP documentation, and deliver right-first-time