Analytical Strategy Lead, Biologics – Associate Director

AstraZeneca

Dublin

On-site

EUR 120,000 - 150,000

Full time

5 days ago

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Job summary

AstraZeneca in Dublin seeks a senior analytical leader to drive lifecycle analytical strategies for commercial biologics, shaping method strategy across product lifecycles and guiding investigations that impact regulatory readiness and supply continuity.

You will partner with Manufacturing, Development, Quality, Regulatory, Supply, and Commercial teams to ensure analytical robustness at every stage and mentor scientists onsite to elevate standards and data‑driven decisions for patients.

Qualifications

Minimum Bachelor’s Degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
Demonstrated (8+ years) 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.

Responsibilities

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.
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.
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.
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.
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.
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.
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.