Associate Director, Analytical Technical 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

Introduction to role:

Are you ready to lead the analytical strategy that safeguards product quality for patients with rare and devastating conditions? Do you thrive on solving complex analytical challenges and influencing decisions across a matrixed organization?

Based in Dublin, you will provide the scientific and technical leadership that keeps our commercial biologics reliable, compliant, and ready for the moments that matter. You will shape method strategy across the product lifecycle, steer high‑impact investigations, and connect laboratory excellence to supply continuity and regulatory success.

You will partner closely with Manufacturing, Development, Quality, Regulatory, Supply, and Commercial teams to ensure analytical robustness at every stage. On‑site presence in the laboratory is part of how you will mentor specialists, elevate standards, and translate data into decisive action for patients.

Accountabilities:

• Analytical Strategy and Study Design: Develop and implement lifecycle analytical strategies for commercial products, including post‑approval changes and method improvements; design and approve studies with clear objectives, sampling plans, acceptance criteria, and statistical approaches aligned to procedures and regulations.
• Method Development, Validation, and Transfer: Provide scientific oversight for development, optimization, qualification, validation, transfer, verification, and lifecycle management of analytical methods; guide seamless transfers between Development, Quality Control, and contract laboratories to ensure right‑first‑time execution.
• Troubleshooting and Technical Investigations: Lead or provide expert support for complex analytical troubleshooting, out‑of‑specification and out‑of‑trend investigations, atypical results, and deviations; drive risk assessments, root‑cause analysis, impact evaluations, and sustainable improvements that strengthen control strategies.
• Regulatory and Technical Documentation: Author, review, and approve analytical content for regulatory and technical documentation; craft responses to regulatory questions and serve as a subject matter expert during inspections; contribute to regulatory strategies for analytical changes, including method and specification updates, site transfers, equipment or material changes, and procedure enhancements.
• Commercial Product Lifecycle Management: Maintain deep product analytical knowledge; ensure control strategies remain current, efficient, scientifically rigorous, and compliant; deliver robust analytical changes that support supply continuity and patient needs in alignment with product technical leadership.
• Study Design and Laboratory Capability Development: Own experimental design, protocols, and reporting; train specialists in relevant techniques and support execution as needed; review laboratory work and technical reports, give constructive feedback, develop training materials, lead workshops, and support qualification of personnel; foster a culture of scientific rigor, data integrity, safety, collaboration, and continuous improvement with an on‑site laboratory presence.
• Stakeholder Engagement and Cross‑Functional Leadership: Act as the analytical voice on cross‑functional product, process, quality, regulatory, and supply teams; communicate risks, study outcomes, and recommendations clearly to technical and non‑technical stakeholders; influence decisions across a matrix to deliver business value.

Essential Skills/Experience:

• Minimum Bachelor’s Degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
• Demonstrated (8 + years) previous experience in an analytical role within a biologics commercial manufacture or development area.
• Experience with analytical techniques such as HPLC or UPLC, CE, ELISA, Bioassay, PCR etc. is essential.
• Experience in GMP laboratory operations and regulated quality systems is preferred.
• Extensive knowledge of analytical method development, validation, verification, transfer and method lifecycle management.
• Experience in study design, experimental planning, risk assessment and statistical data interpretation.
• Experience in authoring and reviewing regulatory documentation is a requirement.
• Experience in analytical comparability and post approval change implementation.
• Experience in software packages (e.g. JMP, Empower and SoftMax Pro).
• Experience in statistical analysis of data.
• A proven track record in stakeholder engagement and influence across a matrixed team.

Desirable Skills/Experience:

• Masters / advanced degree preferred
• Digital and AI savvy

Why AstraZeneca:

Join a team that pairs bold science with deep empathy for people living with rare and devastating conditions. You will work with cutting‑edge analytical technologies alongside colleagues from Manufacturing, Quality, Regulatory, and Development—often in the same room—unlocking faster, smarter decisions that directly impact patients. We combine the autonomy and pace of a biotech with the reach and resources of a global biopharma, empowering you with meaningful responsibility, tailored development, and the chance to lead from the bench to the boardroom. We value kindness alongside ambition, invite diverse perspectives, and back strong science with integrity so you can do the most important work of your career.

Date Posted

22-Sep-2026

Closing Date

05-Oct-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.