Aseptic Manufacturing Front-Line Leader

Amgen Inc.; Dublin; On-site; EUR 80,000 - 110,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Front Line Manager to lead a 20+-person team across a four-cycle shift rotation involved in formulation and aseptic filling of syringes and vials. The role emphasizes safety, quality, and adherence to GMP, with close collaboration across Maintenance, Engineering, Quality and Planning.

The FLM will coach a high-performing team, maintain the production schedule, and drive continuous improvement and lean initiatives.

Qualifications

• Bachelor's degree in Engineering or Science or related discipline.
• Knowledge of GMP, EH&S and regulatory requirements.
• 5+ years' experience in Syringe/Vial aseptic manufacturing operations or equivalent GMP experience.
• Proven experience in managing and leading teams.

Responsibilities

• Model Amgen values and leadership attributes within the manufacturing clean rooms.
• Manage shift of Process Technicians to meet production targets with GMP and safety compliance.
• Lead daily scheduling and team meetings to align activities with the manufacturing plan.
• Maintain the production finite schedule and reflect status of processes.
• Lead root cause analysis and cross-functional problem solving to minimize schedule impact.
• Act as aseptic coach, ensuring aseptic practices in clean rooms.
• Compile and review batch records, EBRs, and SOPs using software systems.
• Collaborate with Quality, Materials, Maintenance, Technical Services and HR to meet department objectives.
• Oversee people management, performance assessments, and MAP development for the shift.
• Identify training needs and coordinate completion via the LMS and production needs.
• Implement lean practices and drive continuous improvement ideas.
• Support audits from corporate, FDA, HPRA and others.

Skills

Leadership

GMP compliance

Problem solving

Lean manufacturing

Team management

Education

Bachelor's degree in Engineering or Science

Tools

PAS/X

QMTS

MAP

Job description

Amgen Dun Laoghaire is seeking a Manufacturing Front Line Manager to lead a 20+-person team across a four-cycle shift rotation involved in formulation and aseptic filling of syringes and vials. The role emphasizes safety, quality, and adherence to GMP, with close collaboration across Maintenance, Engineering, Quality and Planning.

The FLM will coach a high-performing team, maintain the production schedule, and drive continuous improvement and lean initiatives.