Room Lead, Packaging
Core
Lead packaging operations for clinical trial supplies, ensuring safety, quality, and compliance with GMP regulations.
Role type
Senior IC manufacturing operations lead (packaging)
Builds
Clinical trial drug packaging batches
Domain
Biopharmaceuticals / Clinical Supply Services
Required skills
GMP compliance, team leadership, batch record management, 5S principles, waste elimination, troubleshooting, task delegation, safety protocol enforcement, DEA background clearance
Preferred skills
2+ years clinical trial packaging experience, related manufacturing/operations experience
Technologies
Microsoft Outlook, Microsoft Word, Microsoft Excel, inventory systems
Responsibilities
Lead assigned team members to complete clinical trial and commercial packaging jobs daily; ensure strict adherence to hygiene and gowning procedures; maintain accurate and timely entries into batch records; troubleshoot downtime in production rooms; assess operator strengths and weaknesses to assign tasks effectively; oversee multiple ongoing production operations; identify and eliminate waste within production processes.
Seniority
Senior, hands-on IC
