Manufacturing Shift Lead
Core
Lead a team of Bioprocess Technicians to oversee 24/7 biologics manufacturing operations ensuring safety, quality, and operational excellence.
Role type
Senior IC Manufacturing Shift Lead (Biologics)
Builds
Upstream and downstream biologics drug substances
Domain
Biopharmaceutical manufacturing (cGMP)
Required skills
cGMP compliance, upstream/downstream biologics processing, SOP and batch record management, deviation investigation, contamination control, process automation, SAP, TrackWise, Lean thinking, team coaching
Preferred skills
Bachelor's degree in a scientific discipline
Technologies
SAP, TrackWise, process automation platforms
Responsibilities
Lead safe and compliant delivery of production activities against the approved manufacturing schedule; Coordinate shift priorities and maintain clear communication between shifts; Oversee and perform manufacturing activities across upstream and downstream processing areas; Ensure activities are completed in accordance with SOPs, batch records, cGMP requirements and ALCOA+ data integrity principles; Act as a technical subject matter expert for biologics manufacturing and troubleshoot process or equipment issues; Coach and mentor colleagues on process knowledge and SOP execution.