Senior Biotechnologist, MFG (CGT)
Core
Execute cGMP manufacturing activities, aseptic processing, and cleanroom operations for cell and gene therapy treatments.
Role type
Senior Biotechnologist (Manufacturing)
Builds
Innovative cell and gene therapy treatments
Domain
Biopharmaceutical manufacturing / Cell & Gene Therapy
Required skills
cGMP manufacturing, aseptic techniques, cleanroom operations, environmental monitoring, batch record management, deviation investigations, CAPAs, change controls, equipment troubleshooting, process parameter monitoring, team coaching
Preferred skills
Laboratory oversight, continuous improvement initiatives
Technologies
DMS, LIMS, TrackWise
Responsibilities
Execute cGMP manufacturing activities ensuring compliance with aseptic techniques and cleanroom practices; Complete and review Batch Records, logbooks, and GMP documentation; Perform environmental monitoring, equipment preparation, and cleaning; Monitor critical process parameters and troubleshoot issues; Support complex deviation investigations and change controls; Coach and mentor junior team members; Drive continuous improvement initiatives.
Seniority
Senior, hands-on IC with mentorship responsibilities