Biologics Technology Transfer Lead — Scale & Launch

Alexion Pharmaceuticals, Inc.

Dublin

On-site

EUR 140,000 - 190,000

Full time

9 days ago
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Job summary

AstraZeneca in Dublin seeks an experienced Technology Transfer Lead (Associate Director level) to own end-to-end transfer of bulk drug substance processes into the Dublin manufacturing site. You will drive validation readiness, PPQ activities, and robust documentation to enable commercial-scale execution.

Lead SMEs, coordinate with Quality, Supply Chain and Manufacturing ops, and implement AI-enabled improvements to reduce transfer lead times and optimize yields.

Qualifications

  • Minimum 10+ years in Technical Services/Tech Transfer in biopharma.
  • Experience leading a technology transfer initiative.
  • Strong command of cGMP requirements for biologics.
  • Ability to communicate complex science clearly in writing and speech.
  • Proven ability to drive projects in a matrix organization.

Responsibilities

  • Lead multiple bulk drug substance technology transfers to achieve validation readiness.
  • Define and drive validation strategies and PPQ activities.
  • Own process documentation, gap assessments, and technical reports.
  • Identify process improvements, including AI-enabled tools, to shorten cycles.
  • Collaborate with Process Development/MSAT for scale-up decisions.
  • Coordinate BoM, materials readiness, and cross-functional release activities.
  • Lead SMEs teams and provide knowledge transfer to operations.
  • Monitor Changes through formal change control and ensure cGMP compliance.

Skills

Tech Transfer Leadership
cGMP Biopharma
Cross-functional Leadership
Technical Writing
Problem Solving

Tools

AI-enabled tools

Job description

AstraZeneca in Dublin seeks an experienced Technology Transfer Lead (Associate Director level) to own end-to-end transfer of bulk drug substance processes into the Dublin manufacturing site. You will drive validation readiness, PPQ activities, and robust documentation to enable commercial-scale execution.

Lead SMEs, coordinate with Quality, Supply Chain and Manufacturing ops, and implement AI-enabled improvements to reduce transfer lead times and optimize yields.

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