Senior Manufacturing Lead (Aseptic, GMP)

1061 Amgen Technology (Ireland) UC; Dublin; On-site; EUR 56,000 - 76,000; Full time

Job summary

Amgen Inc. is seeking a Manufacturing professional in Ireland to lead a shift of Process Technicians, ensuring GMP-compliant production of sterile parenteral drugs. You will oversee scheduling, quality documentation, and continuous improvement in a fast-paced, regulated environment.

The role requires aseptic knowledge, GMP experience, and strong leadership. Fluency in English and ability to work 24/7 shift patterns are essential.

Qualifications

• Leaving Certificate standard or equivalent.
• A third level qualification in a relevant subject area would be an advantage.
• Relevant experience in sterile pharmaceutical manufacturing or similar environment.
• Aseptic experience preferred.
• Significant GMP/regulatory experience.
• Demonstrated GMP knowledge.
• Aseptic knowledge in GMP areas.
• Drug product manufacturing experience.
• Experience with parenteral manufacturing equipment (autoclaves, filling lines, vessels).
• Ability to deliver team, site and personal objectives.
• Knowledge of right first time and lean manufacturing concepts.
• Results oriented.
• Excellent organizational and communication skills.
• Strong understanding of quality systems in aseptic drug manufacturing.
• Excellent communication skills.
• Team leadership experience preferred.
• Excellent computer skills: Electronic Batch Records, QMS, Performance management Systems.
• Fluent English required.

Responsibilities

• Lead a shift team of Process Technicians to meet production targets.
• Ensure clear direction and information for daily tasks per schedule.
• Manage cross functional alignment across objectives and action plans.
• Maintain an up-to-date manufacturing schedule highlighting critical path activities.
• Promote a strong safety culture and act as a safety role model.
• Review and approve batch records and SOPs.
• Identify and facilitate training needs for area resources.
• Drive continuous improvement using lean principles.
• Identify and resolve process issues to minimize disruptions.
• Support audits by regulatory bodies (FDA, HPRA, etc.).
• Lead the 24/7 shift in the Manufacturing Manager's absence.

Skills

Team leadership

GMP knowledge

Lean manufacturing

Aseptic knowledge

Communication

Results oriented

Problem solving

Education

Leaving Certificate/Equivalent

Third level qualification in relevant subject

Tools

Electronic Batch Records

Quality Management Systems

Performance management systems

Job description

Amgen Inc. is seeking a Manufacturing professional in Ireland to lead a shift of Process Technicians, ensuring GMP-compliant production of sterile parenteral drugs. You will oversee scheduling, quality documentation, and continuous improvement in a fast-paced, regulated environment.

The role requires aseptic knowledge, GMP experience, and strong leadership. Fluency in English and ability to work 24/7 shift patterns are essential.