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
Manufacturing Technical Operations Specialist (MTO Specialist)
Builds
Advanced therapeutic products including AAV and other viral vector-based therapies and vaccines
Domain
Biopharmaceutical manufacturing / Gene therapies
Required skills
GMP regulations knowledge, deviation investigation, root cause analysis, CAPA development, technical documentation, cross-functional leadership, Lean Six Sigma, cleanroom operations
Preferred skills
Equipment operation (incubators, bioreactors, TFF skids, chromatography skids, mixers), in-process testing
Technologies
None explicitly listed beyond general equipment
Responsibilities
Initiate quality records and conduct deviation investigations, Lead or manage investigations including root cause analysis, Develop and oversee Corrective and Preventive Actions (CAPAs), Revise and manage manufacturing documents such as batch records and SOPs, Monitor critical process parameters, Conduct data gathering, trending, and data presentation, Actively participate in training activities and manage individual training plans
Seniority
Mid-Senior level (6-10 years experience required)