Associate Director, External Manufacturing & Operations

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 180,000 - 240,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Dublin is seeking a leader to manage a complex external manufacturing network, turning strategic intent into reliable, compliant supply across multiple CMOs for late-stage and commercial programs.

Based in Dublin, you will partner with CMOs, drive strategy, risk management, and regulatory readiness, shaping the network to deliver medicines to patients efficiently while maintaining high quality standards.

Qualifications

• Minimum 5 years’ experience providing operational/technical support to biologics manufacturing.
• Extensive knowledge of drug substance platforms (mammalian cell culture, microbial, small molecules, peptides, oligonucleotides).
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
• Ability to present and defend technical aspects during regulatory inspections.
• Experience with technology transfers and scale-up of manufacturing processes.
• Experience collaborating with CMOs and influencing cross-functional teams.

Responsibilities

• Lead and direct cross-functional governance with CMOs to meet supply, quality, schedule, and budget.
• Provide operational and technical oversight of drug substance and product manufacturing at CMOs; lead deviation investigations.
• Drive Local and Global Joint Steering Committee engagements to align priorities.
• Identify and implement initiatives to improve efficiency, yield, quality and capacity.
• Co-develop strategies to improve flow and inventory management across the network.
• Provide strategic input on network decisions and cost-of-goods reduction plans with Finance.
• Develop risk-based oversight models with CMO partners.
• Drive regulatory inspection readiness and SME input for IND/BLA and other filings.
• Visit CMO sites to strengthen relationships and accelerate issue resolution.

Skills

Operational leadership

Biologics manufacturing

cGMP knowledge

Regulatory inspections

Technology transfer

Cross-functional collaboration

Strategic planning

BS in science/engineering

Education

BS in Scientific or Engineering field

Advanced degree desirable

Job description

Alexion Pharmaceuticals, Inc. in Dublin is seeking a leader to manage a complex external manufacturing network, turning strategic intent into reliable, compliant supply across multiple CMOs for late-stage and commercial programs.

Based in Dublin, you will partner with CMOs, drive strategy, risk management, and regulatory readiness, shaping the network to deliver medicines to patients efficiently while maintaining high quality standards.