Manufacturing Manager

Manufacturing Manager – Manufacturing Support

Level 5 | Amgen Dun Laoghaire, Dublin

Overview

The Manufacturing Manager – Manufacturing Support reports to the Senior Manager Manufacturing and provides leadership, strategic direction and technical oversight for the Aseptic & Process Owner team supporting Formulation and Aseptic Filling operations, including ADL2.

The role is accountable for ensuring that manufacturing processes remain safe, compliant, in a state of control and capable of reliably delivering product in accordance with current Good Manufacturing Practice (GMP), approved process requirements and site business objectives.

This includes leadership of process ownership, operational readiness, quality-system execution, process monitoring, continuous improvement and cross-functional issue resolution.

The Manufacturing Manager sets clear priorities, manages resources and develops team capability to meet production, quality, safety and project commitments. The role partners closely with Manufacturing, Quality, Engineering, Process Development, Supply Chain and other site functions to deliver complex initiatives, maintain a robust contamination-control and quality culture, and strengthen operational performance.

This position requires broad aseptic drug-product manufacturing, process-owner, technical-transfer and compliance knowledge, together with the ability to translate complex technical and quality information into clear, actionable plans. The successful candidate will identify process gaps, manage significant issues and risks, implement sustainable improvements, and influence stakeholders at all levels.

This is a hybrid role requiring onsite presence three days per week.

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, escalate 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.

Qualifications and Relevant Experience

• 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.
• Demonstrated experience in aseptic processing, process ownership, manufacturing-support operations, technical transfer, validation or lifecycle management.
• Experience leading cross-functional teams and managing multiple complex projects simultaneously.
• Demonstrated experience with quality systems, including deviations, investigations, CAPAs, change controls and CAPA effectiveness verifications.
• Working knowledge of contamination-control strategy, aseptic process simulation principles and inspection readiness.
• Strong written and verbal communication, facilitation and presentation skills.
• Demonstrated leadership, coaching, negotiation and influencing capability.
• Ability to operate effectively in complex and ambiguous environments.
• Strong problem-solving, decision-making, risk-management and continuous-improvement skills.
• Excellent teamwork skills, with a collaborative, accountable and results-focused approach.