- Dublin, Leinster, Ireland
- On-site
- Full-time · Manager
- 10+ years
Lead complex biologics technology transfers of bulk drug substance processes into the Dublin manufacturing facility, ensuring validation readiness and compliant execution.
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 delivery of process documentation, gap assessments, technical protocols and reports, and strategy documents
- Identify and implement process improvements, including AI-enabled tools, to reduce transfer lead times
- Determine requirements for supporting lab studies and partner with Process Development/MSAT on design and execution
Requirements
- Nice to have: Leadership of PPQ and process validation strategies in commercial bulk drug substance facilities
- Nice to have: Proficiency with Quality Risk Management tools and structured risk assessments
- Nice to have: Experience implementing AI-enabled or digital tools to reduce transfer timelines
- Nice to have: Experience authoring and reviewing CTD sections and engaging as an SME during regulatory inspections
- Nice to have: Proven capability leading plant-scale studies and providing on-the-floor support during engineering and validation runs