Manufacturing Program Manager – NPI & CAPEX (Aseptic)

Biopharma Careers; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire, Dublin, seeks a Manufacturing Manager (Manufacturing Support) to oversee NPI, lifecycle changes and CAPEX projects for Formulation and Aseptic Filling. The role leads a team, mentors staff, and ensures safety and compliance with GMP/GxP while driving process improvements and coordinating with QA, regulatory and operations.

The candidate will manage project plans, resource allocation, and cross-functional collaboration, while upholding patient safety and product quality

Qualifications

• Bachelor’s degree in Engineering or Science.
• Strong GMP and GxP knowledge.
• Experience leading cross-functional teams on multiple projects.
• Excellent communication, facilitation and presentation skills.
• 5+ years in Syringe/Vial aseptic Drug Product manufacturing or equivalent leadership.

Responsibilities

• Monitor resources and training models to meet project targets.
• Build collaborative relationships within teams.
• Coach and develop Operations Leads.
• Promote a culture of safety on site.
• Deliver project plans in line with manufacturing and project requirements.
• Communicate relevant 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 process improvements.
• Support quality system investigations ensuring timely and effective actions to protect product quality and patient safety.
• Contribute to audits by regulatory bodies.

Skills

GMP/GxP knowledge

Leadership

Communication

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or Science

Job description

Amgen Dun Laoghaire, Dublin, seeks a Manufacturing Manager (Manufacturing Support) to oversee NPI, lifecycle changes and CAPEX projects for Formulation and Aseptic Filling. The role leads a team, mentors staff, and ensures safety and compliance with GMP/GxP while driving process improvements and coordinating with QA, regulatory and operations.

The candidate will manage project plans, resource allocation, and cross-functional collaboration, while upholding patient safety and product quality