Are you ready to turn disciplined manufacturing into therapies that make a tangible difference for people living with complex, often rare conditions?
Can you see yourself shaping robust operations that deliver right-first-time results at scale?
Based at College Park, Dublin, you will be part of a dedicated team that supports bulk drug substance operations.
Your work will strengthen how we execute, train, and continuously improve, building a culture where people are empowered to perform at their best.
In this role, your technical leadership and attention to detail will directly influence the quality, safety, and reliability of each batch—and the impact patients feel beyond our walls.
Accountabilities: - Technical and Documentation Leadership: Provide expert support to investigations, CAPAs, change controls, training, and improvement projects to ensure safe, compliant, cost-effective BDS manufacture aligned to cGMP and regulatory commitments.
- Compliance and Safety Assurance: Champion manufacturing practices that meet health authority submissions and local Health and Safety requirements, sustaining audit-ready performance and risk-aware operations.
- New Product Introduction Enablement: Contribute end-user operational requirements into the design, commissioning, and validation of equipment, automation, and processes, enabling smooth, right-first-time start-ups.
- Procedures and Records Ownership: Lead the development of operations procedures, batch records (electronic or paper), and associated documentation; deliver technical training so Operations teams execute with confidence and consistency.
- Human Error Reduction: Establish work practices and procedures that minimize human error; collaborate with continuous improvement teams to identify and remove error sources, increasing reliability and throughput.
- Project Leadership and KPI Delivery: Successfully lead teams to deliver project requirements for cost, time, and functionality; achieve KPI targets while embedding sustainable improvements.
- Cross-functional Collaboration and Best Practice Sharing: Build strong relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, and Finance; lead and contribute to best-practice sharing across facilities and the wider industry.
Essential Skills/Experience: - Demonstrated experience providing expert technical and documentation support to investigations, CAPAs, change controls, training, and improvement projects in a cGMP manufacturing environment.
- Track record ensuring bulk drug substance manufacture is safe, compliant, and cost-effective in line with health authority submissions, cGMPs, and local Health and Safety requirements.
- Hands-on experience contributing end-user operations requirements to the design, commissioning, and validation of equipment, automation, and processes during routine new product introductions.
- Proven ability to develop operations procedures, batch records (electronic or paper), and associated documentation, coupled with delivering technical training to Operations teams.
- Experience establishing work practices and procedures that minimize human error and partnering with continuous improvement teams to remove sources of error.
- Successful leadership of teams to deliver project requirements for cost, time, and functionality, consistently achieving KPI targets.
- Ability to develop and maintain effective relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, and Finance, and to lead and contribute to best-practice sharing across facilities and the industry.
Desirable Skills/Experience: - Experience in biologics bulk drug substance operations and tech transfer within commercial or clinical manufacturing.
- Proficiency with electronic batch record systems and manufacturing automation platforms.
- Formal training or certification in Lean, Six Sigma, or human factors.
- Experience operating in highly regulated environments with frequent audits and inspections.
- Strong communication skills enabling influence across diverse stakeholder groups and sites.
Why AstraZeneca: At AstraZeneca, we stay close to the people and families behind every medicine, learning from their lived experiences to guide how we design, make, and deliver.
You will work in an energizing environment that blends the autonomy of a biotech mindset with the scale and resources of a global biopharmaceutical leader.
We bring unexpected teams into the same room to unleash bold thinking, and we value kindness alongside ambition.
Your manufacturing expertise will accelerate therapies for those with the greatest unmet needs, supported by development that grows your skills and deepens your understanding of the patients behind every batch.
Call to Action: Step into a role where your expertise drives reliable BDS manufacturing at College Park, Dublin—and turn disciplined execution into life-changing impact.
Date Posted 22-Jan-**** Closing Date 04-Feb-****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.