Technical Transfer Lead - Biologics Bulk Drug Substance

About the role

AstraZeneca is looking for a Technical Transfer Lead (Associate Director level) to own the end-to-end transfer of bulk drug substance processes into its Dublin manufacturing facility. The role ensures validation readiness and robust, compliant execution, partnering with Process Development, Operations, Engineering, Supply Chain, Quality and Regulatory to deliver right-first-time transfers and shorten the timeline from initiation to PPQ completion.

Key responsibilities

• Lead multiple technology transfers of bulk drug substance processes to achieve process validation readiness and on-time PPQ completion
• Define and execute validation strategies, author validation documentation and guide PPQ activities
• Own process documentation, gap assessments, technical protocols, reports and strategy documents
• Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times and improve yield
• Determine requirements for supporting lab studies and partner with Process Development/MSAT on design and execution
• Deliver materials lists and Bills of Materials, coordinating raw material and consumable readiness with Quality and Supply Chain
• Build and guide teams of transfer SMEs, covering cell culture and downstream purification, and provide knowledge transfer to Technical Services and Operations
• Generate protocols, lead plant supporting studies and provide hands-on support during engineering and validation batches
• Lead troubleshooting, root cause analysis and corrective actions, and manage process changes through formal change control
• Ensure adherence to EHS policy, cGMP and regulations, and author and review CTD sections and technical reports
• Serve as SME for technology transfer and PPQ during health authority inspections and provide periodic out-of-hours support

Required profile

• Minimum 10+ years' experience in Technical Services / Technology Transfer Manufacturing in a biological bulk drug substance organisation, including leading a Technology Transfer
• Knowledge of multiple unit operations in upstream and downstream processing and of cGMP requirements for biopharmaceutical manufacturing
• Ability to work in a matrix organisation and to present and defend technical approaches in written and verbal form
• Desirable: proven leadership of PPQ and process validation, experience with CTD authoring, plant-scale studies, change control, deviation management and root cause analysis, and willingness to support shift work and on-call coverage

Required skills

• Technical writing and supporting documentation for electronic batch records
• Advantageous: Quality Risk Management tools, statistical analysis, and experience implementing AI-enabled or digital tools to shorten transfer timelines