Operations Lead

About the role

The Operations Lead will be the primary owner of production processes for new product introductions, lifecycle management, CAPEX projects and continuous improvement initiatives. Based on‑site at Amgen’s Dun Laoghaire facility, you will coordinate manufacturing activities across syringe and vial lines to drive efficiency and compliance.

Key responsibilities

• Act as the interface between Product Delivery Teams and manufacturing operations, ensuring clear communication and alignment.
• Develop, review and approve Generic Master Batch Records, Parameter Value Lists, and Bills of Materials for formulation, filling and inspection.
• Maintain and update production, engineering, and operating procedures, as well as training materials.
• Support scheduling and execution of characterization, engineering and PPQ runs, monitoring performance data.
• Provide troubleshooting support during projects and routine floor activities.
• Lead change controls, job hazard assessments and change control assessments.
• Collaborate with Quality Assurance, Learning & Performance, Process Development and other functions to ensure GMP compliance.

Required profile

• Strong background in aseptic drug product manufacturing, including syringe filling, vial filling and lyophilisation.
• Experience managing complex projects and cross‑functional teams in a regulated environment.
• Proven ability to develop and approve batch records, SOPs and risk assessments.
• Excellent analytical and troubleshooting skills with a focus on process efficiency.

Required skills

• Aseptic manufacturing processes
• Syringe and vial filling operations
• Lyophilisation and capping techniques
• GMP compliance and documentation
• Change control management
• Product quality risk assessment
• Process improvement methodologies