Hybrid Aseptic Manufacturing Manager

Biopharma Careers; Dublin; Hybrid; EUR 79,000 - 106,000; Full time

Job summary

Amgen is seeking a Manufacturing Manager – Manufacturing Support in Dublin to lead the Aseptic & Process Owner team for Formulation and Aseptic Filling, ensuring validated, compliant, inspection-ready processes throughout the product lifecycle.

You will drive process performance monitoring, develop the team, manage capacity and lead tech transfers, changes and continuous-improvement initiatives in a hybrid role requiring onsite presence three days per week.

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.
• 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.

Skills

GMP knowledge

Aseptic manufacturing

Process ownership

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Science or a related discipline

Job description

Amgen is seeking a Manufacturing Manager – Manufacturing Support in Dublin to lead the Aseptic & Process Owner team for Formulation and Aseptic Filling, ensuring validated, compliant, inspection-ready processes throughout the product lifecycle.

You will drive process performance monitoring, develop the team, manage capacity and lead tech transfers, changes and continuous-improvement initiatives in a hybrid role requiring onsite presence three days per week.