Senior Technical Lead, CSO Packaging and Labelling
Core
Senior Technical Lead responsible for end-to-end delivery of clinical supply packaging and labelling projects, ensuring supplies reach patients at the right time for clinical trials.
Role type
Senior Technical Lead, Clinical Supply Operations
Builds
Clinical trial packaging and labelling solutions for early- and late-stage development portfolios
Domain
Pharmaceutical clinical trials / Clinical Supply Chain
Required skills
Clinical packaging and labelling expertise, cGMP and regulatory requirements knowledge, SAP (process orders/purchasing), Project management, Vendor/CMO relationship management, Quality risk management and root-cause analysis, Deviation ownership and investigation
Preferred skills
Experience leading multiple concurrent global projects, AI tool adoption for supply planning, Process improvement methodologies
Technologies
SAP, ERP/MRP systems
Responsibilities
Lead end-to-end delivery of clinical supply projects including packaging, labelling, and production plans; Manage detailed project schedules coordinating drug product, packaging components, and label text; Act as subject matter expert providing technical input to development matrix teams; Generate and approve packaging and labelling production orders and Bills of Materials; Lead operational delivery of outsourced packaging activities with external partners; Maintain quality and compliance by managing deviations, change controls, and root-cause investigations; Provide technical leadership, guidance, and coaching to the team.
Seniority
Senior, hands-on IC with leadership responsibilities