Manufacturing Technical Operations Specialist III (MTO Specialist)
Core
Ensure batch record review and disposition schedules are met to adhere to lot release dates in a CGMP manufacturing facility for gene therapies.
Role type
Senior Manufacturing Technical Operations Specialist (GMP)
Builds
Advanced therapeutic products including AAV and other viral vector-based therapies and vaccines
Domain
Biopharmaceutical manufacturing / Gene therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge, deviation investigation, root cause analysis, CAPA development, technical documentation authoring, cross-functional leadership, Lean Six Sigma, sterile gowning, cleanroom operations
Preferred skills
Equipment operation (incubators, bioreactors, TFF skids, chromatography skids, mixers), in-process testing
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Initiate quality records and conduct deviation investigations, lead root cause analysis and assess product impact, develop and oversee CAPAs, revise manufacturing documents and SOPs, monitor critical process parameters, support technology transfer and process monitoring, lead continuous improvement projects, perform on-the-floor response for operational deviations
Seniority
Senior, hands-on IC
