Senior Analytical Strategy Lead, Biologics

Alexion Pharmaceuticals, Inc.

Dublin

Hybrid

EUR 130,000 - 170,000

Full time

5 days ago

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Job summary

AstraZeneca–Alexion seeks an Associate Director, Analytical Technical Lead to shape analytical strategy across the product lifecycle, ensuring robust methods and regulatory readiness. Based in Dublin, you will partner with Manufacturing, Development, Quality, Regulatory, Supply, and Commercial teams to drive data-driven decisions and ensure uninterrupted supply of commercial biologics.

You will lead method development, validation, transfer, troubleshooting, and studies design, delivering

Qualifications

Bachelor's degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
8+ years' analytical experience in biologics manufacturing or development.
Experience with analytical techniques like HPLC/UPLC, CE, ELISA, Bioassay, PCR.
GMP laboratory operations and regulated quality systems preferred.
Experience in method development, validation, transfer and lifecycle management.
Experience in study design, risk assessment and statistical data interpretation.
Experience in regulatory document authoring/review.

Responsibilities

Develop and implement lifecycle analytical strategies for commercial products.
Provide oversight of method development, validation, transfer, and lifecycle management.
Lead troubleshooting, investigations, risk assessments, and root-cause analysis.
Author/review regulatory content and support inspections.
Maintain robust analytical knowledge to support supply continuity and regulatory success.