Aseptic Manufacturing Start-Up Leader

Amgen SA; Ireland; Remote; EUR 140,000 - 180,000; Full time

Job summary

Amgen Dun Laoghaire seeks a Senior Manager Manufacturing to lead start-up, operational readiness and transition to commercial operation of manufacturing activities. You will oversee aseptic filling, formulation, parts preparation and material supply, building a capable, compliant organisation with a focus on safety, quality and digital-enabled processes.

As part of the Manufacturing Leadership Team, you will drive PPQ readiness, develop leadership across the site, and partner with Quality,

Qualifications

• Minimum 8+ years in pharmaceutical or regulated manufacturing environments.
• 4+ years of people management and leadership experience.
• Experience leading teams through significant change, scale-up, start-up, commissioning, qualification, PPQ or commercial launch.
• Bachelor's degree or equivalent experience.

Responsibilities

• Lead the Manufacturing Operational Readiness programme for Aseptic Filling, Formulation, Parts Preparation and Material Supply, ensuring readiness for PPQ and commercial launch.
• Provide visible operational leadership for aseptic manufacturing activities, ensuring GMP compliance and inspection readiness.
• Recruit, coach and develop Manufacturing Managers and frontline leadership, building a strong leadership pipeline.
• Establish and sustain a safety, quality, compliance and patient-focused culture from day one.

Skills

Leadership

Operational Readiness

GMP

Change management

Digital mindset

Data-driven

Cross-functional collaboration

Aseptic manufacturing

Education

Bachelor's degree

Job description

Amgen Dun Laoghaire seeks a Senior Manager Manufacturing to lead start-up, operational readiness and transition to commercial operation of manufacturing activities. You will oversee aseptic filling, formulation, parts preparation and material supply, building a capable, compliant organisation with a focus on safety, quality and digital-enabled processes.

As part of the Manufacturing Leadership Team, you will drive PPQ readiness, develop leadership across the site, and partner with Quality,