Senior QC Analyst: Method Transfer & Validation Lead

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 65,000 - 95,000; Full time

Job summary

AstraZeneca is seeking a QC Senior Analyst focused on Analytical NPI to transfer, validate, and troubleshoot methods for clinical and commercial supply. You will anchor technical work in a cGMP lab and support rapid, inspection-ready outcomes.

Join a team delivering high- urgency, precise analytical support for new therapies, with opportunities to influence technology adoption and continuous improvement across the NPI function.

Qualifications

• In-depth knowledge of regulatory requirements for chemistry/biochemistry methods in cGMP for clinical and commercial manufacturing.
• Strong technical foundation in Biochemistry or Chemistry.
• Experience in investigation methodologies and method troubleshooting.

Responsibilities

• cGMP laboratory excellence with data integrity and audit readiness.
• Lead method transfer and validation studies aligned to regulatory and manufacturing timelines.
• Troubleshoot new methods and provide SME guidance for NPI activities.
• Lead investigations/CAPAs with root-cause analysis and preventive actions.
• Serve as training lead for selected assays and ensure qualified performance.
• Drive continuous improvement to increase robustness and reduce cycle time.
• Evaluate new analytical technologies to boost performance and data quality.
• Maintain training compliance and documentation throughout method lifecycle.

Skills

Regulatory knowledge

Biochemistry/Chemistry know‑how

Investigation/troubleshooting

Procedure compliance

Technical writing

AI-assisted writing

Independent work

Bachelor level science background

Education

BSc in Chemistry or biological science

Tools

LIMS

Empower/Chromeleon

Electronic Quality Systems

Job description

AstraZeneca is seeking a QC Senior Analyst focused on Analytical NPI to transfer, validate, and troubleshoot methods for clinical and commercial supply. You will anchor technical work in a cGMP lab and support rapid, inspection-ready outcomes.

Join a team delivering high- urgency, precise analytical support for new therapies, with opportunities to influence technology adoption and continuous improvement across the NPI function.