Executive Lead, External Manufacturing Network

AstraZeneca plc; Dublin; Hybrid; EUR 150,000 - 210,000; Full time

Job summary

AstraZeneca plc in Dublin is seeking a senior leader to manage an external manufacturing network for biologics. You will translate strategic intent into operational excellence across CMOs, ensuring compliant, reliable supply for patients with rare diseases.

You will shape network strategy, oversee regulatory readiness, and drive cost-of-goods reduction while collaborating with Finance, Quality, and Supply teams.

Qualifications

• Minimum 5 years’ experience in providing operational / technical support to biologics product manufacturing.
• Extensive knowledge of a variety of drug substance manufacturing platforms (such as mammalian cell culture, microbial fermentation, small molecules, peptides, oligonucleotides, etc.), drug product and finished product.
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Demonstrated experience with technology transfers and scale-up of manufacturing processes.
• Experience of working with CMOs demonstrating strong communication and influencing skills.
• Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.

Responsibilities

• Lead and direct cross-functional, tiered governance with CMOs to meet supply, quality, schedule, and budget objectives; proactively surface and resolve issues and manage risks end-to-end.
• Provide deep operational and technical expertise across drug substance and drug product manufacturing at CMOs; lead troubleshooting and high-level deviation investigations with internal partners.
• Lead Local and Global Joint Steering Committee engagements, driving clear decisions and internal cross-functional alignment on priorities and trade-offs.
• Identify and implement initiatives that improve efficiency, yield, quality, and capacity; bring together and scale standard methodologies across the network.
• Co-develop strategies that improve success rates and flow through the value chain; partner across functions to maintain optimal months-on-hand inventory.
• Provide strategic operational input to network decisions (including CMO selection and S&OP) and partner with Finance to deliver and track cost-of-goods reduction plans.
• Build and deploy a right-sized oversight approach with CMO partners to focus attention where it creates the most value as the portfolio grows.
• Drive perfection in PAI and routine cGMP inspections; provide SME input for IND, BLA, and other regulatory submissions supporting CMO-operated processes.
• Visit CMO sites routinely to strengthen relationships, verify performance, and accelerate issue resolution.

Skills

Biologics manufacturing

CMO management

cGMP knowledge

Regulatory inspections

Technology transfer

Stakeholder management

BS degree in science/engineering

Education

BS in Scientific/Engineering field

Advanced degree (MS/PhD)

Job description

AstraZeneca plc in Dublin is seeking a senior leader to manage an external manufacturing network for biologics. You will translate strategic intent into operational excellence across CMOs, ensuring compliant, reliable supply for patients with rare diseases.

You will shape network strategy, oversee regulatory readiness, and drive cost-of-goods reduction while collaborating with Finance, Quality, and Supply teams.