cGMP Production Manager
Core
End-to-end cGMP production, packaging, and labeling execution for clinical trial materials, ensuring audit-ready operations and regulatory compliance.
Role type
Senior IC cGMP Production Manager (packaging & labeling)
Builds
Compliant clinical trial packaging and labeling batches
Domain
Pharmaceutical clinical supply chain / cGMP manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP batch execution, label design and artwork control, MBR/EBR management, ERP system proficiency, vendor coordination, process optimization, change control, global standardization
Preferred skills
Strategic thinking, complex problem solving, cross-functional collaboration, audit support
Technologies
ERP systems
Responsibilities
Execute GMP production activities including room setup, batch execution, in-process checks, and line clearance; Maintain audit-ready production suites and compliance with GMP/GDP/SOPs; Serve as global production SME for troubleshooting and technical guidance; Verify readiness of materials, labels, and equipment; Create and maintain MBRs/EBRs and control label templates/artwork; Partner with Regulatory and Quality on packaging designs and client approvals; Manage BOMs and master data in ERP; Coordinate vendor sourcing and supplier qualification; Drive process optimization and global standardization initiatives.
