Manufacturing Program Lead - NPI, CAPEX & Aseptic Ops

Amgen SA; Ireland; Remote; EUR 85,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Manager (Manufacturing Support) to oversee NPI, LC changes and CAPEX projects for Formulation and Aseptic Filling. You will manage project staffing, mentor staff, and drive process improvements while ensuring compliance and patient safety.

In this role, you will coordinate with cross-functional teams, schedule resources, and report to senior management. Strong GMP knowledge and a proven leadership track record are essential for success.

Qualifications

• Bachelor’s degree in Engineering or Science.
• 5+ years’ experience in syringe/vial aseptic drug product manufacturing or related leadership.
• Strong GMP and GxP knowledge.
• Excellent written and verbal communication and leadership skills.

Responsibilities

• Monitoring resources and training models to meet project targets.
• Builds collaborative relationships within team and other departments.
• Coach and develop team of Operations Leads.
• Promotes a culture of safety, ensuring the team is engaged with safety initiatives.
• Deliver project plans in accordance with manufacturing and project requirements.
• Effectively communicate information to peers, operators, cross functional departments, and senior management.
• Act as a delegate for the Senior Manager Manufacturing as required.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide expertise for quality system investigations ensuring timely assessment of events and actions.
• Contribute to audits by corporate, FDA, HPRA and other regulatory bodies.

Skills

GxP knowledge

Leadership

Project management

Cross-functional teamwork

Communication skills

Education

Bachelor’s degree in Engineering or Science

Job description

Amgen Dun Laoghaire is seeking a Manufacturing Manager (Manufacturing Support) to oversee NPI, LC changes and CAPEX projects for Formulation and Aseptic Filling. You will manage project staffing, mentor staff, and drive process improvements while ensuring compliance and patient safety.

In this role, you will coordinate with cross-functional teams, schedule resources, and report to senior management. Strong GMP knowledge and a proven leadership track record are essential for success.