Aseptic Manufacturing Leader – Process Ownership

Amgen Inc. (IR); Dublin; Hybrid; EUR 79,000 - 106,000; Full time

Job summary

Amgen Dun Laoghaire in Dublin seeks a Manufacturing Manager – Manufacturing Support to lead the Aseptic & Process Owner team for Formulation and Aseptic Filling, ensuring GMP compliance, validated processes, and readiness for inspections.

Hybrid role with onsite presence three days per week. You will monitor processes, drive CAPA, change control and tech transfers, and collaborate with Quality, Engineering and Supply Chain to ensure safe, high-quality medicines.

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• Strong GMP and GxP knowledge and experience in aseptic drug-product manufacturing.
• Experience leading cross-functional teams and managing complex projects.

Responsibilities

• Provide leadership for the Aseptic & Process Owner team and manufacturing-support activities.
• Ensure processes are validated, controlled and inspection-ready throughout the product lifecycle.
• Lead process performance monitoring, data review, and risk elevation with appropriate actions.
• Coach and develop the team; establish goals, priorities and development plans.
• Drive change controls, CAPAs and validation activities; support technology transfers.

Skills

Leadership

Aseptic manufacturing

Process ownership

GxP know-how

Cross-functional leadership

Data analysis

Quality systems

Communication skills

Regulatory readiness

Problem solving

Education

Bachelor’s degree in Engineering or Science

Tools

Change-control system

CAPA system

Process validation tools

Job description

Amgen Dun Laoghaire in Dublin seeks a Manufacturing Manager – Manufacturing Support to lead the Aseptic & Process Owner team for Formulation and Aseptic Filling, ensuring GMP compliance, validated processes, and readiness for inspections.

Hybrid role with onsite presence three days per week. You will monitor processes, drive CAPA, change control and tech transfers, and collaborate with Quality, Engineering and Supply Chain to ensure safe, high-quality medicines.