Head of External Plant Operations & CMO Partnerships

Alexion Pharma Spain S.L.; Blanchardstown; Hybrid; EUR 140,000 - 180,000; Full time

Job summary

AstraZeneca is seeking an Associate Director for External Plant Operations to lead a complex network of CMOs, driving operational excellence from late-stage clinical through commercial supply. Based in Dublin, you will shape network strategy, ensure regulatory readiness, and elevate performance across the external manufacturing landscape.

You will partner with internal teams and CMOs, overseeing governance, risk management, and continuous improvement to ensure reliable, compliant supply of

Qualifications

• Minimum 5 years’ operational/technical support to biologics manufacturing.
• Broad knowledge of biologics manufacturing platforms (cell culture, microbial, small molecules, peptides, oligos).
• Extensive understanding of cGMP for clinical and commercial manufacturing.
• Experience presenting technical aspects during regulatory inspections.
• Experience with technology transfers and scale-up of processes.
• Demonstrated ability to work with CMOs and influence stakeholders.
• Strong strategic thinking and risk management skills.
• Experience contributing to PPQ/validation and inspection readiness.

Responsibilities

• Lead cross-functional governance with CMOs to meet supply, quality, schedule and budget goals.
• Provide operational/technical leadership across drug substance and product manufacturing at CMOs.
• Drive regulatory readiness and successful inspections, including SME input for IND/BLA submissions.
• Develop and implement process improvements to yield, quality, and capacity across the network.
• Navigate S&OP and cost-of-goods reduction initiatives in collaboration with finance.

Skills

Biologics manufacturing

CMO partnerships

cGMP compliance

Regulatory readiness

Technology transfer

Stakeholder influence

Risk management

Process optimization

Education

BS in scientific or engineering

Job description

AstraZeneca is seeking an Associate Director for External Plant Operations to lead a complex network of CMOs, driving operational excellence from late-stage clinical through commercial supply. Based in Dublin, you will shape network strategy, ensure regulatory readiness, and elevate performance across the external manufacturing landscape.

You will partner with internal teams and CMOs, overseeing governance, risk management, and continuous improvement to ensure reliable, compliant supply of