Senior External Manufacturing Lead

AstraZeneca

Dublin

Hybrid

EUR 150,000 - 190,000

Full time

5 days ago
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Job summary

AstraZeneca in Ireland seeks a Senior leader to manage an external manufacturing network delivering biologics therapies. You will translate strategy into operational excellence across CMOs, ensuring compliant supply from late-stage clinical through commercial operations.

Based in Dublin, you will shape network strategy, drive inspection readiness, and contribute to regulatory filings while partnering with internal teams.

Qualifications

  • Minimum 5 years’ experience enabling operations for biologics manufacturing.
  • Extensive knowledge across drug substances and products.
  • Deep understanding of cGMP for clinical and commercial manufacturing.
  • Experience presenting technical aspects during regulatory inspections.
  • Proven track record with technology transfers and scale‑up.
  • Experience collaborating with CMOs and cross‑functional teams.
  • BS in Scientific or Engineering field.

Responsibilities

  • Lead cross‑functional governance with CMOs to meet supply, quality, and budget objectives.
  • Provide operational and technical oversight of drug substance and product manufacturing at CMOs.
  • Drive network strategy, inspection readiness, and regulatory filing support.
  • Identify and implement process improvements to yield, quality, and capacity.
  • Co‑develop end‑to‑end supply optimization and inventory strategy.
  • Lead risk-based oversight and governance models across the network.
  • Visit CMOs to strengthen performance and issue resolution.

Skills

Leadership
Strategic thinking
Risk management
Cross-functional collaboration
Influencing skills
Regulatory interactions

Education

BS degree in Science or Engineering

Tools

Quality systems knowledge

Job description

AstraZeneca in Ireland seeks a Senior leader to manage an external manufacturing network delivering biologics therapies. You will translate strategy into operational excellence across CMOs, ensuring compliant supply from late-stage clinical through commercial operations.

Based in Dublin, you will shape network strategy, drive inspection readiness, and contribute to regulatory filings while partnering with internal teams.

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