Technical Transfer Lead
Core
Lead end-to-end technology transfer of bulk biologics drug substance processes into commercial manufacturing facilities, ensuring validation readiness and compliant execution.
Role type
Senior IC Technical Transfer Lead (Associate Director)
Builds
Commercial-scale biologics drug substance manufacturing processes
Domain
Biopharmaceutical manufacturing (Upstream/Downstream)
Required skills
End-to-end technology transfer leadership, cGMP compliance, upstream/downstream unit operations, validation strategy (PPQ), process documentation, cross-functional orchestration, root cause analysis, change control, EHS policy adherence, technical writing, statistical analysis
Preferred skills
AI-enabled tool implementation, Quality Risk Management, regulatory inspection support (CTD authoring), plant-scale study execution, deviation management, raw material introduction coordination
Technologies
AI-enabled tools, electronic batch records, change control systems, Quality Risk Management tools
Responsibilities
Lead multiple technology transfers to achieve validation readiness and on-time PPQ completion; Define and execute validation strategies and author documentation; Identify and implement process improvements including AI tools; Partner with Process Development/MSAT on scale-up studies; Build and guide teams of transfer SMEs; Lead troubleshooting and manufacturing investigations; Author CTD sections and support regulatory inspections; Provide on-the-floor support during engineering and validation batches.
Seniority
Senior, hands-on IC with leadership responsibilities