BDS Manufacturing Operations Lead

AstraZeneca; Dublin; On-site; EUR 150,000 - 210,000; Full time

Job summary

AstraZeneca in Dublin seeks a senior operations leader to direct end-to-end biologics drug substance manufacturing, ensuring safety, quality and reliability. You will guide upstream and downstream workflows to release, drive continuous improvement, and champion digital tools that deliver measurable value in a fast-evolving portfolio.

The role demands a track record of leading high-performing teams, managing regulatory expectations, and partnering across functions to optimize throughput and

Qualifications

• 12+ years in pharmaceutical or biopharmaceutical manufacturing operations, quality, or technical services, with biology drug substance experience preferred.
• Proven risk, quality, and regulatory management at high standards.
• Strong leadership, communication, and negotiation capabilities.
• Experience with digital transformation and AI in operations.
• Demonstrated change leadership in dynamic environments.
• Deep knowledge of global GMP and regulatory inspections.

Responsibilities

• Set vision for resilient, compliant, and efficient manufacturing at the Dublin site.
• Lead upstream/downstream operations from processing to product release.
• Drive continuous improvement and seamless new product introductions.
• Champion digital adoption and predictive maintenance initiatives.
• Mentor teams, manage change, and foster a safety-first culture.
• Collaborate with EHS, Quality, Engineering, and Supply Chain to remove barriers.
• Communicate milestones, risks, and decisions to leadership with data-backed insights.
• Oversee budgets and drive cost-efficient operations with strong controls.

Skills

Leadership

Regulatory acumen

GMP expertise

Digital & AI integration

Change management

Cross-functional collaboration

Education

Undergraduate degree in Science or Engineering

MS/PhD or MBA (Desirable)

Job description

Introduction to role:

Are you ready to lead end-to-end biologics drug substance manufacturing and build an operation that never wavers on safety, quality, and reliability? Do you want your decisions in Dublin to translate directly into consistent supply for patients living with rare and devastating conditions?

Based at our College Park, Dublin campus and reporting to the Senior Director, Operations, you will join the site’s Operations Leadership Team to set a clear vision for resilient, compliant, and efficient manufacturing. You will steer upstream and downstream operations through to product release, championing continuous improvement and seamless new product introductions. While you will deploy digital and AI tools where they deliver measurable value, your primary focus is rock-solid operations that safeguard product quality and patient safety.

This is a role for a decisive leader who thrives at the intersection of people, process, and performance—someone who can set direction, inspire teams, and deliver results under regulatory scrutiny and in a rapidly evolving portfolio.

Accountabilities:

• Operational Resilience and Accountability: Establish and sustain robust, high-reliability processes with contingency readiness; proactively identify, mitigate, and elevate operational risks to uphold the highest standards of safety, quality, and compliance.
• Digital and AI Integration: Evaluate and implement practical digital and AI solutions that improve yield, throughput, monitoring, and predictive maintenance; grow digital literacy across teams to embed new ways of working.
• Team Leadership: Build, inspire, and retain a first-class manufacturing organization; set clear expectations, develop talent, and create a culture where safety, compliance, and continuous improvement are non-negotiable.
• Cross-Functional Collaboration: Orchestrate seamless interactions with EHS, Quality Assurance, Engineering, Technical Services, and Supply Chain to remove barriers, align priorities, and deliver dependable production.
• Change Leadership: Act as a visible change agent; mentor teams through organizational and process changes, build advocacy across the site and wider business, and ensure adoption sticks.
• Production Performance and Sustainability: Own and communicate performance metrics; manage capacity and cycle times; drive initiatives that increase throughput, reduce variability, and deliver cost and sustainability gains.
• Regulatory Excellence and NPI: Lead the site confidently through inspections, submissions, and licensure activities; ensure flawless tech transfers, new product introductions, and process improvements without disruption.
• Stakeholder Communication: Provide timely, transparent updates on milestones, risks, and key decisions to senior and corporate stakeholders; bring data-driven insight and clear recommendations.
• Financial Stewardship: Manage significant budgets with rigor; strengthen financial controls; deliver cost-efficient operations using proven methods and targeted digital enhancements.

Essential Skills/Experience:

• Experience: Minimum 12 years in pharmaceutical or biopharmaceutical manufacturing operations, quality, and/or technical services, with a preference for biological drug substance experience and multi-area expertise.
• Operational Resilience: Demonstrated ability to build resilient, high-performing operations and proactively manage risk, quality, and compliance at the highest standards.
• People Leadership: Exceptional talent management and team-building experience, with strong motivational, communication, and negotiation skills.
• Digital & AI Acumen: Practical experience with digital transformation and AI-enabled tools in operations; able to mentor staff in adopting new technologies as part of broader operational excellence.
• Change Management: Clear evidence of successfully leading organizational change and supporting continuous improvement in dynamic, fast-paced environments.
• Regulatory Know-How: Deep knowledge of global GMP and regulatory requirements for clinical and commercial drug substance facilities, plus proven success in regulatory inspections and product launches.
• Education: Undergraduate degree in Science or Engineering.

Desirable Skills/Experience:

• Advanced Education: MS, PhD, or MBA.
• Self-Starter: Highly proactive and resourceful, motivated by both immediate operational needs and long‑term strategic vision.
• Innovator: Strong continuous improvement focus, applying process excellence and digital tools to optimize outcomes.
• Business Acumen: Extensive understanding of manufacturing, engineering, logistics, inventory, and supply chain in GMP environments.
• Communication: Skilled communicator, comfortable managing up, down, and across functions, and leading both written and oral presentations to diverse audiences.

Why AstraZeneca:

Join a company that blends the energy of a cutting‑edge biotech with the scale and stability of a global biopharma. You will work shoulder‑to‑shoulder with scientists, operators, data specialists, engineers, and quality leaders—unexpected teams in the same room unleashing bold thinking to solve real manufacturing challenges. Your work directly supports patients with serious and often rare conditions, giving purpose to every batch released. We back ambition with support: modern technology, investment in capability, and leaders who value kindness alongside high standards. Here, you can shape an operation built for today and ready for tomorrow, and see the impact of your leadership in the lives of patients and the growth of your career.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.