Technical Transfer Lead

Job description

Are you ready to lead complex biologics technology transfers that directly accelerate life-changing therapies to patients? As Technology Transfer Lead (Associate Director level), you will own the end-to-end transfer of bulk drug substance processes into our Dublin manufacturing facility, ensuring validation readiness and robust, compliant execution. Your leadership will turn scientific innovation into reliable, commercial-scale reality. You will partner across Process Development, Operations, Engineering, Supply Chain, Quality, and Regulatory to deliver right-first-time transfers, shorten timelines from initiation to PPQ completion, and embed continuous improvement. Can you see yourself orchestrating cross-functional teams, strengthening SME capability, and applying digital tools to remove bottlenecks while safeguarding compliance and product quality? Accountabilities: End-to-End Technology Transfer Leadership: Lead multiple technology transfers of bulk drug substance processes to achieve process validation readiness and on-time PPQ completion. Validation Readiness and PPQ: Define and execute validation strategies, author validation documentation, and guide PPQ activities to meet regulatory and business milestones. Process Documentation and Strategy: Own delivery of process documentation, gap assessments, technical protocols and reports, and strategy documents that enable robust commercial execution. Continuous Improvement and AI Enablement: Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times, improve yield, and shorten cycle times. Laboratory and MSAT Interface: Determine requirements for supporting lab studies; partner with Process Development/MSAT on design and execution to de-risk scale-up and transfer decisions. Materials and BoM Introduction: Deliver materials lists and Bills of Materials; coordinate raw material and consumable readiness with Quality and Supply Chain for timely availability and release. SME Team Leadership: Build and guide multiple teams of transfer SMEs; develop strategies and technical capability across cell culture and downstream purification operations. Knowledge Transfer and Training: Provide comprehensive knowledge transfer to Technical Services and Operations to ensure right-first-time manufacturing start-up. Cross-Functional Orchestration: Align with Quality, Supply Chain, and Manufacturing Operations to maintain schedule integrity for transfer and routine production. Plant Studies and On-the-Floor Execution: Generate protocols and lead plant supporting studies; provide hands-on support at commercial scale during engineering and validation batches. Issue Resolution and Investigations: Lead troubleshooting and manufacturing investigations; drive root cause analysis and sustainable corrective actions. Change Control and Compliance: Lead process changes via formal change control; embed corporate and site standards for Quality, Safety, and compliance. EHS and cGMP Excellence: Ensure adherence to EHS policy, cGMP, and applicable regulations; participate in risk assessments, audits, and incident investigations. Regulatory Authoring and Inspection Support: Author and review CTD sections and technical reports; serve as SME for technology transfer and PPQ during health authority inspections. Flexibility and On-Call Support: Provide periodic out-of-hours support during critical engineering and validation activity to secure schedule and quality outcomes. Essential Skills/Experience: • Minimum 10+ years’ experience in Technical Services / Technology Transfer Manufacturing in a biological bulk drug substance manufacturing organization including previous experience of leading a Technology Transfer • Technical and operational knowledge of multiple unit operations in upstream and downstream processing • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings • Ability to present and defend technical and scientific approaches in both written and verbal form • Ability to drive for results independently and adapt to changing priorities • Experience of Technology Transfer and statistical analysis is advantageous • Detail orientated • Technical writing competency • Experience in developing supporting documentation for electronic batch records. Desirable Skills/Experience: • Demonstrated leadership of PPQ and process validation strategies in commercial bulk drug substance facilities • Proficiency with Quality Risk Management tools and structured risk assessments • Experience implementing AI-enabled or digital tools to reduce transfer timelines, improve yield, and optimize cycle time • Experience authoring and reviewing CTD sections and engaging as an SME during regulatory inspections • Proven capability leading plant-scale studies and providing on-the-floor support during engineering and validation runs • Strong experience with change control systems, deviation management, and root cause analysis • Coordination of raw material introduction and BoM creation for new processes • Willingness to support periodic shift work and on-call coverage during critical validation and engineering activities Why AstraZeneca: Here, science meets purpose with urgency and care. You will join a collaborative biologics manufacturing community focused on rare and devastating diseases, where translating complex biology into dependable, commercial-scale processes changes real lives. We bring unexpected teams into the same room to unleash bold thinking, pairing cutting-edge platforms and digital innovation with a culture that values kindness alongside ambition. Your leadership in technology transfer will directly shorten the path from discovery to treatment, while you grow alongside peers who challenge, support, and inspire one another to aim higher for patients. Call to Action: If you are ready to lead high-impact technology transfers that bring transformative biologics to patients faster, step forward and shape what’s next. Date Posted 02-Sep-2026 Closing Date 15-Sep-2026 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.