Director - Chemical Development, Small Molecule API APICOM

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 2026. 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&D and Chemical Development

Pharmaceutical Technology & Development (PT&D) turns brilliant science into medicines for millions of patients. Within PT&D, Chemical Development designs routes, develops processes, and handles lifecycle performance for >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 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&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), 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-2025

Closing Date

31-Jul-2025

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.