Senior Biologics Tech Transfer Leader

AstraZeneca GmbH; Dublin; On-site; EUR 140,000 - 190,000; Full time

Job summary

AstraZeneca Dublin is seeking a Technology Transfer Lead (Associate Director level) to own end-to-end transfers of bulk drug substance processes into our manufacturing site. You will ensure validation readiness, drive compliant execution, and partner across Process Development, Operations, Engineering, Quality, and Regulatory.

You will lead cross-functional teams, embed continuous improvement, and apply digital tools to shorten timelines from initiation to PPQ, while safeguarding product quality

Qualifications

• 10+ years in Technical Services / Technology Transfer Manufacturing in a biological bulk drug substance facility.
• Deep understanding of unit operations in upstream and downstream processing.
• Strong knowledge of cGMP for biopharma manufacturing.
• Proven ability to operate in a matrix organization and communicate effectively.

Responsibilities

• Lead multiple technology transfers to achieve validation readiness and PPQ on time.
• Define and execute validation strategies and author validation documentation.
• Own process documentation, gap assessments, protocols and reports for robust execution.
• Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times.
• Coordinate raw material and BoM readiness with Quality and Supply Chain.
• Provide hands-on support for scale-up and plant studies during engineering and validation.

Skills

Technology Transfer

Biopharma

cGMP

Process Validation

Documentation

Root Cause Analysis

Cross-functional Leadership

AI/Digital Tools

Tools

CTD Authoring

Electronic Batch Records

Quality Risk Management

Job description

AstraZeneca Dublin is seeking a Technology Transfer Lead (Associate Director level) to own end-to-end transfers of bulk drug substance processes into our manufacturing site. You will ensure validation readiness, drive compliant execution, and partner across Process Development, Operations, Engineering, Quality, and Regulatory.

You will lead cross-functional teams, embed continuous improvement, and apply digital tools to shorten timelines from initiation to PPQ, while safeguarding product quality