Senior Analytical Strategy Lead – Biologics

AstraZeneca GmbH; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca GmbH in Dublin is seeking a senior analytical leader to drive strategy for commercial biologics, ensuring quality, compliance, and supply continuity. You will shape method strategy across product lifecycles, oversee investigations, and connect laboratory excellence to regulatory success.

On-site collaboration with Manufacturing, Quality, Regulatory, Development and Commercial teams; mentoring analysts, elevating standards, and translating data into decisive actions for patients.

Qualifications

• Bachelor-level degree in a relevant scientific discipline required.
• 8+ years' experience in analytical role within biologics manufacturing or development.
• Experience with analytical techniques such as HPLC/UPLC, CE, ELISA, Bioassay, PCR is essential.
• GMP laboratory operations and regulated quality systems preferred.
• Extensive knowledge of method development, validation, 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.
• Experience with JMP, Empower and SoftMax Pro.
• Strong statistical data interpretation and data integrity awareness.
• Proven track record in stakeholder engagement across a matrixed team.

Responsibilities

• Develop and implement lifecycle analytical strategies for commercial products, incl. post-approval changes.
• Provide scientific oversight for development, optimization, validation, transfer, and lifecycle management of analytical methods.
• Lead or support troubleshooting, investigations, and risk assessments with root-cause analysis.
• Author and review analytical content for regulatory/technical documentation; assist in inspections.
• Maintain deep product analytical knowledge and ensure control strategies are current and compliant.
• Own experimental design, protocols, reporting; train specialists and support qualification of personnel.
• Act as analytical voice on cross-functional teams and communicate risks and outcomes clearly.

Skills

Analytical leadership

Cross-functional collaboration

Problem solving

Communicating with stakeholders

Regulatory documentation

Risk assessment

Data interpretation

Attention to detail

Education

Bachelor's degree in biochemistry, chemistry, microbiology or relevant scientific discipline

Master's degree preferred

Tools

JMP

Empower

SoftMax Pro

Job description

AstraZeneca GmbH in Dublin is seeking a senior analytical leader to drive strategy for commercial biologics, ensuring quality, compliance, and supply continuity. You will shape method strategy across product lifecycles, oversee investigations, and connect laboratory excellence to regulatory success.

On-site collaboration with Manufacturing, Quality, Regulatory, Development and Commercial teams; mentoring analysts, elevating standards, and translating data into decisive actions for patients.