Job Title: Director - Chemical Development, Small Molecule API Location: Dublin Competitive salary and benefits Introduction to role Join AstraZeneca to shape how small-molecule APIs are developed, transferred, and validated for commercial supply.
You will build and lead a multidisciplinary laboratory team co-located with our new API commercialisation facility near Dublin, creating the blueprint for right-first-time validation and accelerated launches from a digitally enabled, paperless factory.
About the facility and mission We are constructing a next-generation small-molecule API launch facility at AstraZeneca College Park, Dublin, operational in early ****.
The site will maximise continuous processing, advanced analytics, and digital innovations to compress tech-transfer timelines and deliver medicines faster, more cost-effectively, and sustainably.
This is a rare greenfield opportunity to define standards, systems, and ways of working that will scale across AstraZeneca's portfolio.
About PT set technical standards and operating model.
Late-stage development : Team will design and execute process characterisation, link CPPs to CQAs, and define control strategies and PAT.
Create strong links with the global Chemical Development to inject manufacturability thinking into development plans and methods Partner with Process Technology : Partner closely with the site Process Technology team to co-design development plans, align on RFT objectives, and assemble and apply plant learnings to refine control strategy and operating standards Tech transfer and validation : Govern stage gates; align with QA/Validation/Manufacturing; review key documents; deliver PPQ readiness and first-time validation.
Manufacturing support : Provide first-line technical leadership on complex process deviations, root cause analysis, and corrective actions; reduce start-up variability.
Knowledge management and digital : Implement digital tools and data integrity practices to accelerate development and transfer; bring together process knowledge for lifecycle management.
Lab start-up and compliance : Commission laboratory capability; ensure SHE and cGMP compliance; introduce new technologies aligned to site strategy.
Influence and governance : Represent Chemical Development on the APICOM leadership team; build strong interfaces across PT comfortable with change and ambiguity; drives novel, practical solutions Thorough understanding of regulatory expectations (ICH Q8–Q11), cGMP, SHE, and data integrity Demonstrated problem-solving depth and commitment to continuous learning Desirable Experience deploying digital tools for development, knowledge management, and tech transfer External collaboration leadership (CDMOs, academia/consortia) and scientific visibility (publications, patents, talks) Lean/operational excellence to improve productivity in manufacture and in ways of working Facility start-up experience Date Posted 17-Jul-**** Closing Date 31-Jul-****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.