Lead, Manufacturing - Cell Culture (Nights)
Core
Lead manufacturing operations for upstream cell culture processes in a cGMP environment, ensuring compliance, equipment maintenance, and shift coordination.
Role type
Senior IC manufacturing lead (cell culture)
Builds
Upstream cell culture manufacturing batches and process outputs
Domain
Biotechnology / Pharmaceutical manufacturing
Required skills
cGMP compliance, upstream cell culture operations, aseptic/cleanroom environment management, manufacturing system proficiency (Trackwise, Delta V, Syncade, LIMS), SOP adherence, deviation investigation, team training and mentorship
Preferred skills
bioreactor operations, media preparation, harvest operations, aseptic cell expansion
Technologies
Trackwise, Delta V, Syncade, LIMS
Responsibilities
Execute cell culture manufacturing steps and monitor performance against batch records; coordinate shift activities and resource planning with the Shift Manager; document and verify cGMP data and deviations; train and mentor manufacturing associates; lead troubleshooting and corrective/preventive actions
Seniority
Senior, hands-on IC