Associate Director: Biologics Analytical Strategy Lead

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Dublin seeks an experienced scientific leader to shape analytical strategy across the product lifecycle for rare disease biologics.

You will guide method development, validation, transfer, investigations, and regulatory documentation, partnering with Manufacturing, Quality, Regulatory, and Commercial teams to ensure analytical robustness and supply continuity. The role demands deep expertise in analytical methods (HPLC/UPLC, CE, ELISA, Bioassay, PCR), GMP

Qualifications

• Bachelor’s degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
• 8+ years of analytical experience in a biologics commercial manufacture or development.
• Experience with HPLC/UPLC, CE, ELISA, Bioassay, PCR.
• GMP lab operations and regulated quality systems.
• Extensive knowledge of analytical method development, validation, verification, transfer and lifecycle management.
• Experience in study design, risk assessment and statistical data interpretation.
• Experience in authoring and reviewing regulatory documentation.
• Experience in analytical comparability and post-approval change implementation.
• Proficiency with JMP, Empower and SoftMax Pro; strong statistical analysis skills.
• Proven stakeholder engagement across cross-functional teams.

Responsibilities

• Develop lifecycle analytical strategies for commercial products including post‑approval changes and method improvements.
• Provide oversight for development, validation, transfer, verification and lifecycle management of analytical methods.
• Lead investigations and deviations; drive risk assessments and corrective actions.
• Author and review analytical content for regulatory documentation and inspections.
• Maintain robust control strategies aligned with product lifecycle and supply continuity.
• Own experimental design, protocols, reporting, and training of staff; foster scientific rigor and data integrity.
• Engage cross‑functionally to communicate risks and outcomes to technical and non‑technical stakeholders.

Skills

Analytical strategy

GMP operations

Analytical methods

Regulatory docs

Statistical analysis

Stakeholder engagement

Cross-functional leadership

Analytics software

Education

Bachelor's in biosciences

Masters preferred

Tools

JMP

Empower

SoftMax Pro

Job description

Alexion Pharmaceuticals, Inc. in Dublin seeks an experienced scientific leader to shape analytical strategy across the product lifecycle for rare disease biologics.

You will guide method development, validation, transfer, investigations, and regulatory documentation, partnering with Manufacturing, Quality, Regulatory, and Commercial teams to ensure analytical robustness and supply continuity. The role demands deep expertise in analytical methods (HPLC/UPLC, CE, ELISA, Bioassay, PCR), GMP