Hybrid Aseptic Manufacturing Manager & Process Lead

Amgen; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Amgen Dun Laoghaire, Dublin is looking for a Manufacturing Manager – Manufacturing Support to lead the Aseptic & Process Owner team across Formulation and Aseptic Filling, including ADL2. The role ensures GMP-compliant, validated and inspection-ready production while driving continuous improvement and site prioritization.

This hybrid position requires onsite presence three days a week, with collaboration across Manufacturing, Quality, Engineering and Process Development to deliver complex

Qualifications

• Bachelor’s degree in Engineering, Science or a related discipline.
• Strong knowledge of GMP and applicable GxP requirements.
• Minimum of five years’ experience in aseptic drug-product manufacturing operations, preferably in syringe and/or vial filling, or demonstrated people-leadership experience with the ability to rapidly learn and adapt to new technologies.

Responsibilities

• Provide leadership and strategic oversight for the Aseptic & Process Owner team and manufacturing-support activities across Formulation and Aseptic Filling, including ADL2.
• Ensure assigned manufacturing processes remain in a validated, controlled and inspection-ready state throughout the product lifecycle.
• Own and drive process performance monitoring, including review of process, operational and quality data; identify adverse trends, elevate risks and lead appropriate actions.
• Lead, coach and develop the team; establish clear goals, priorities, accountabilities, succession plans and individual development plans.
• Plan and manage team capacity, training models and project resourcing to deliver manufacturing targets, operational-readiness activities and agreed milestones.
• Provide technical and operational leadership for aseptic manufacturing operations, including escalation support for significant manufacturing events, recurring issues and product-quality risks.
• Champion adherence to contamination-control strategy principles, aseptic behaviours and practices, and continuous strengthening of aseptic process control.
• Ensure robust process ownership of manufacturing procedures, master batch records, manufacturing instructions and associated process documentation.
• Lead and support the assessment, implementation and effectiveness of process changes through the site change-control system, ensuring appropriate technical, quality and regulatory impact assessment.
• Provide manufacturing leadership for technology transfers, process-validation activities, engineering studies, comparability assessments and implementation of new or modified processes, as applicable.
• Deliver integrated project plans in accordance with approved manufacturing, quality and business requirements.
• Provide quality-record oversight, ensuring timely, accurate and compliant management of deviations, investigations, CAPAs, change controls and CAPA effectiveness verifications.
• Ensure investigations appropriately establish root cause, assess impact to product quality and patient safety, identify effective corrective and preventive actions, and are progressed to closure in accordance with quality-system requirements.
• Monitor quality-record trends and recurring issues; drive sustainable actions to strengthen compliance, improve right-first-time performance and prevent recurrence.
• Identify, evaluate and implement continuous-improvement opportunities that improve safety, compliance, process robustness, operational efficiency and project execution.
• Partner closely with Manufacturing, Quality, Engineering, Process Development, Supply Chain and other site functions to resolve issues, manage risk and deliver site priorities.
• Promote a strong safety culture and ensure active team engagement with site safety, environmental, and wellbeing initiatives.
• Communicate project, operational, technical and quality information effectively to operators, peers, cross-functional stakeholders and senior leadership.
• Support site inspections and audits by corporate, FDA, HPRA and other regulatory authorities, including preparation, front-room/back-room support, response coordination and follow-up actions.
• Act as delegate for the Senior Manager Manufacturing, as required.

Skills

GMP knowledge

Aseptic manufacturing

Leadership

Cross-functional leadership

Process ownership

Risk management

Education

Bachelor’s degree in Engineering/Science or related

Tools

Change-control system

Job description

Amgen Dun Laoghaire, Dublin is looking for a Manufacturing Manager – Manufacturing Support to lead the Aseptic & Process Owner team across Formulation and Aseptic Filling, including ADL2. The role ensures GMP-compliant, validated and inspection-ready production while driving continuous improvement and site prioritization.

This hybrid position requires onsite presence three days a week, with collaboration across Manufacturing, Quality, Engineering and Process Development to deliver complex