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…