QC Separation Sciences Lead — Lean & Right-First-Time

Biopharma Careers; Dublin; On-site; EUR 80,000 - 110,000; Full time

Job summary

Amgen in Dun Laoghaire – Dublin seeks a Separation Sciences: QC Manager to lead the In-process team and oversee QCSS activities ensuring release and stability testing comply with cGMP and GDP. The role drives lean culture and Right First Time (RFT) initiatives across QC.

The site emphasizes continuous improvement and requires flexible, cross-functional collaboration with internal and external stakeholders, under minimal supervision with escalation as needed.

Qualifications

• Bachelor's degree in Science required.
• 6+ years of biopharmaceutical QC experience or related GMP laboratory experience.
• Experience with regulatory compliance in cGMP manufacturing and testing.

Responsibilities

• Supervise/manage QC Separation Sciences and In-process team.
• Provide Quality oversight to ensure operations meet cGMP, GDP and applicable regs.
• Coach, give feedback and mentor for team development.
• Collaborate cross-functionally with ADL and Network colleagues to share improvements.
• Investigate and document deviations per procedures.
• Represent QC during audits and inspections.

Skills

Quality leadership

Analytical skills

Communication

GMP documentation

Process improvement

Team coaching

Education

Bachelor's degree in Science

Tools

LIMS

HPLC

Job description

Amgen in Dun Laoghaire – Dublin seeks a Separation Sciences: QC Manager to lead the In-process team and oversee QCSS activities ensuring release and stability testing comply with cGMP and GDP. The role drives lean culture and Right First Time (RFT) initiatives across QC.

The site emphasizes continuous improvement and requires flexible, cross-functional collaboration with internal and external stakeholders, under minimal supervision with escalation as needed.