Biotechnologist, MFG (CGT)
Core
Perform cGMP manufacturing activities, aseptic processing, and cleanroom operations for cell and gene therapy products.
Role type
Manufacturing Biotechnologist (CGT)
Builds
Cell and gene therapy medicines
Domain
Biopharmaceutical manufacturing / Cell & Gene Therapy
Required skills
cGMP principles, aseptic techniques, cleanroom operations, data integrity, environmental monitoring, electronic systems operation (DMS, LIMS, TrackWise), deviation management, CAPA support
Preferred skills
Biopharmaceutical manufacturing knowledge, prior industry experience
Technologies
DMS, LIMS, TrackWise
Responsibilities
Perform cGMP manufacturing activities in accordance with aseptic techniques and cleanroom practices; Complete and review Batch Records, logbooks, and GMP documentation; Perform environmental monitoring and routine production support; Operate electronic systems to support manufacturing and quality activities; Identify and escalate deviations and non-routine events; Maintain training compliance and support quality activities; Participate in continuous improvement initiatives
Seniority
Entry-level to Mid-level, hands-on IC