Senior Biologics Technology Transfer Lead

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 190,000 - 230,000; Full time

Job summary

AstraZeneca is seeking an experienced Technology Transfer Lead (Associate Director level) for our Dublin facility. You will own end‑to‑end bulk drug substance transfers, drive validation readiness, and coordinate cross‑functional teams across Process Development, Operations, Engineering, Quality, and Regulatory.

In this senior role you will lead multiple transfers, define validation strategies, author critical documents, and implement AI-enabled improvements to shorten timelines while

Qualifications

• Minimum 10+ years’ experience in Technical Services / Technology Transfer Manufacturing in a biological bulk drug substance manufacturing organization including previous experience of leading a Technology Transfer.
• Technical and operational knowledge of multiple unit operations in upstream and downstream processing.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Good interpersonal skills in matrix organizations and local groups.
• Ability to present and defend technical approaches in written and spoken form.
• Ability to drive for results independently and adapt to changing priorities.
• Experience of Technology Transfer and statistical analysis is advantageous.
• Detail oriented and strong technical writing competency.
• Experience developing documentation for electronic batch records.

Responsibilities

• Lead multiple technology transfers of bulk drug substance processes to achieve validation readiness and on-time PPQ completion.
• Define and execute validation strategies, author validation documentation, and guide PPQ activities to meet regulatory milestones.
• Own delivery of process documentation, gap assessments, technical protocols and reports, and strategy documents.
• Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times and improve yield.
• Provide hands-on support at commercial scale during engineering and validation batches.

Skills

Tech Transfer Leadership

Cross-functional collaboration

Biopharma manufacturing

Project management

AI/digital tools

Process optimization

Tools

CTD writing

AI-enabled tools

Job description

AstraZeneca is seeking an experienced Technology Transfer Lead (Associate Director level) for our Dublin facility. You will own end‑to‑end bulk drug substance transfers, drive validation readiness, and coordinate cross‑functional teams across Process Development, Operations, Engineering, Quality, and Regulatory.

In this senior role you will lead multiple transfers, define validation strategies, author critical documents, and implement AI-enabled improvements to shorten timelines while