Location Dublin, Leinster, Ireland
Job ID R-227647
Date posted 27/05/2025
Are you ready to lead and innovate in the realm of drug product manufacturing? As the Associate Director of Drug Product at Alexion Technical Operations, you’ll be at the forefront of ensuring technical excellence at Contract Manufacturing Organizations (CMOs) for commercial product production. This pivotal role demands strong scientific leadership across technology transfer, validation, commercial manufacturing, process scale-up, inspections, process monitoring, and troubleshooting. You’ll foster dynamic cross-functional relationships with internal and external teams to drive successful technology transfer of new products and support regulatory submissions for commercial products manufactured at CMOs. Are you prepared to make a significant impact?

Accountabilities

• Provide technical and scientific direction for the production of drug product at CMOs.
• Lead technical initiatives for transferring new products and processes.
• Support risk assessments for new product implementation and contribute to DFM (Design for Manufacturability) initiatives.
• Manage day-to-day technical support to meet manufacturing or CMO shutdown schedules while maintaining high GMP compliance.
• Align manufacturing schedules with corporate goals through continuous communication with internal partners.
• Guide process validation programs for all DP manufacturing processes at CMOs.
• Offer technical input to Process Development for defining critical process parameters of new processes.
• Author technical documents for regulatory submissions and serve as a subject-matter expert during inspections.
• Lead process monitoring and statistical analysis of manufacturing operations.
• Drive troubleshooting efforts and lead high-level deviation investigations with Alexion QA and CMO teams.
• Identify and lead process optimization initiatives for efficiency and capacity improvements.
• Communicate operational status of CMOs to management through written documents and oral presentations.
• Up to 20% international travel may be required.

Essential Skills/Experience

• Comprehensive understanding of Technical/cGMP requirements for commercial manufacturing of Drug products.
• Excellent communication and influencing skills enabling them to influence both internal and external partners.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Advanced degree in engineering or comparable industry experience.

Desirable Skills/Experience

• Knowledge of lyophilization and filling of different modalities.
• Knowledge of medical combination devices filling such pre-filled cartridges and syringes.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.
At AstraZeneca, you’ll find an environment where innovation thrives and your career can flourish. With the entrepreneurial spirit of a leading biotech combined with the resources of a global pharma, you’ll be part of a team dedicated to making a difference in patients’ lives. Our commitment to high standards ensures that we protect our patients, our people, and our planet. Here, you’re encouraged to take ownership, explore new ideas, and expand your skills in a supportive community.
Ready to embark on this exciting journey? Apply now and become part of a team that is redefining the future of healthcare!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

Please refer the Job description for details