60 commercial APIs.
The Dublin laboratory expands our global Chemical Development organisation (currently centred in Macclesfield) to partner closely with the API commercialisation team at site.
Role scope
You will establish and lead the Dublin Chemical Development laboratory and team of chemists, analysts, and chemical engineers.
Your team will own late‑stage process characterisation, enable seamless tech transfer into the commercial facility, and ensure right‑first‑time validation.
You will also provide authoritative support to manufacturing during early commercial phase and drive continuous improvement in process robustness and methods.
Accountabilities:
Build and lead the lab and team: Hire, develop, and inspire a high‑performing, multidisciplinary group; 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 c GMP compliance; introduce new technologies aligned to site strategy.
Influence and governance: Represent Chemical Development on the APICOM leadership team; build strong interfaces across PT&D, QA, Validation, EHS, and Supply.
What success looks like
PPQ completed on plan with right‑first‑time validation
Reduced TT cycle times and early commercial deviation rates
Robust control strategies and measurable process capability (e.g., Cp/Cpk)
Effective cross‑functional governance and inspection‑ready documentation
Engaged, growing team with strong retention and development
Essential qualifications and experience
Degree (or higher) in Organic Chemistry, Chemical Engineering, or related field
Significant experience in drug substance late‑stage development and technology transfer understanding of GMP manufacture
Consistent record in process design, characterisation, control strategy and PAT, and PPQ/validation execution
Strong leadership with experience building teams and leading cross‑functional delivery
Excellent communicator and doer; comfortable with change and ambiguity; drives novel, practical solutions
Thorough understanding of regulatory expectations (ICH Q8–Q11), c GMP, 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-2025
Closing Date
31-Jul-2025
Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at Astra Zeneca 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.
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