Introduction to role
Lead and develop high-performing Technical Services teams across bulk drug substance, finished product packaging and device assembly operations in Dublin. This role provides technical oversight to ensure robust, reliable and efficient manufacturing performance, while driving the introduction of new products and technologies into the site. Take ownership of the site’s Contamination Control Strategy at senior leadership level, embedding best practices and continuous improvement. Champion the adoption of AI, data analytics and advanced manufacturing technologies to deepen process understanding, enhance quality and improve yields and cost of goods. Shape how cutting-edge biologics and combination products are reliably supplied to patients with rare diseases
Accountabilities
- Provide strategic and hands-on leadership for Technical Services teams supporting BDS manufacturing (mammalian cell culture and downstream processing), finished product packaging and device assembly operations, ensuring consistent process performance and compliance.
- Lead New Product Introduction and technology transfer activities into the Dublin site, including process validation, cleaning validation, new material introduction and associated regulatory documentation and approvals.
- Oversee receiving-site design transfer for new vial packaging and combination product assembly processes, ensuring robust project management, clear milestones and effective cross-functional collaboration.
- Partner closely with Process Development, Engineering and Automation to define and implement robust process control strategies, including risk assessments, control plans and documentation to support equipment and automation qualification.
- Own the site Contamination Control Strategy from a senior leadership perspective, continuously assessing effectiveness through risk assessments, process monitoring and targeted improvements.
- Engage a broad network of subject matter experts and stakeholders to identify, adapt and deploy current industry, regulatory and network best practices in contamination prevention across all manufacturing areas.
- Drive the deployment and integration of AI, data analytics and digital tools within Technical Services to monitor process performance, detect adverse trends early and implement data-driven yield improvements.
- Lead investigation of significant deviations and process issues, ensuring timely root cause analysis, effective CAPA implementation and sustainable risk reduction.
- Identify and deliver process optimisation initiatives that improve robustness, yields and cost of goods, leveraging deep process understanding and advanced analytics.
- Provide technical leadership during regulatory inspections, acting as a subject matter expert on technology transfer, process validation, control strategies and ongoing process verification.
- Oversee the authoring, review and approval of CMC sections for regulatory submissions and responses, ensuring scientific rigour, clarity and alignment with global standards.
- Recruit, retain and develop outstanding technical and scientific talent, building a strong pipeline of future leaders and maintaining high levels of current technical expertise within the Technical Services organisation.
- Foster a culture of safety, quality, integrity and continuous improvement across all Technical Services activities, aligned with the mission of serving people living with rare diseases.
Essential Skills/Experience
- Batchelors degree in a relevant Science or Engineering discipline
- In-depth technical and operational knowledge of biopharmaceutical manufacturing processes.
- A high degree of digital fluency and experience of deploying and leading implementation AI and Data Analytics.
- Proven expertise in successful execution and management of technology transfer and process support within a commercial facility.
- Demonstrated ability to build, organize and lead a technical team to deliver on corporate goals.
- Strong interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
- Demonstrated ability to present and defend technical and scientific approaches in both written and verbal form, including during regulatory agency inspections.
Desirable Skills/Experience
- Masters degree or post graduate qualification in a science, engineering or business discipline.
- Leadership experience over technical teams and personal expertise across multiple technology platforms or modalities.
AstraZeneca offers the opportunity to work at the forefront of rare disease science, where complex biology is translated into transformative medicines for some of the most underserved patients in the world. With the scale, resources and global reach of a leading biopharmaceutical company combined with the agility and spirit of a biotech environment, teams are empowered to innovate, learn and grow while staying closely connected to the patients whose lives are impacted. Colleagues collaborate across disciplines in an inclusive culture that values integrity, curiosity and meaningful contribution, enabling long-term career development while advancing pioneering therapies that change lives every day.
If this role resonates and there is a desire to lead technical excellence that directly supports people living with rare diseases, please apply now.
Date Posted
10-Jul-2026
Closing Date
19-Jul-2026
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.
