Biologics Tech Transfer Lead: Scale-Up & Validation

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

Job summary

AstraZeneca is seeking a highly experienced Technical Transfer Lead to spearhead complex biologics technology transfers at our Dublin site. You will own end-to-end transfer activities, ensuring validation readiness, and collaborate across Process Development, Operations, Engineering, Quality, and Regulatory to deliver right-first-time results.

The role emphasizes leadership of cross-functional teams, development of strategies for validation and documentation, and leveraging digital tools to

Qualifications

• Minimum 10+ years’ experience in Technical Services / Technology Transfer Manufacturing in a biological bulk drug substance facility.
• Proven leadership of cross-functional teams in a matrix organization.
• Strong knowledge of unit operations in upstream and downstream processing.
• Solid understanding of cGMP requirements for biopharmaceutical manufacturing.

Responsibilities

• Lead end-to-end technology transfer of bulk drug substance processes to ensure validation readiness.
• Define and drive validation strategies and PPQ activities.
• Own process documentation, technical protocols and reports.
• Identify and implement process improvements including AI-enabled tools to reduce transfer lead times.

Skills

Technology Transfer

Biologics manufacturing

cGMP compliance

Cross-functional leadership

Process validation

AI enablement

Tools

CTD writing

Job description

AstraZeneca is seeking a highly experienced Technical Transfer Lead to spearhead complex biologics technology transfers at our Dublin site. You will own end-to-end transfer activities, ensuring validation readiness, and collaborate across Process Development, Operations, Engineering, Quality, and Regulatory to deliver right-first-time results.

The role emphasizes leadership of cross-functional teams, development of strategies for validation and documentation, and leveraging digital tools to