Manager, MSAT Validation & LCM
Core
Lead process validation and lifecycle management for a new commercial cell therapy manufacturing facility, ensuring cGMP compliance and operational efficiency.
Role type
Manager, Process Validation & Lifecycle Management (Cell Therapy)
Builds
Commercial cell therapy products for patients with blood cancer
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing validation)
Required skills
cGMP regulations, facility/clean room design, process validation, aseptic process simulation, process performance qualification, data analysis, risk mitigation, change control management, regulatory inspection readiness, continuous improvement
Preferred skills
Advanced degree in science/engineering/biochemistry
Technologies
None explicitly listed
Responsibilities
Lead validation activities for new products or processes; Execute Aseptic Process Simulations/Validations (APS/APV) and Process Performance Qualifications (PPQ); Design and execute test plans and risk mitigation exercises; Interface with process engineers as validation SME; Lead site implementation of lifecycle management changes; Support equipment and facility commissioning and qualification; Lead site change controls; Participate in facility and process risk assessments; Ensure safe and compliant cGMP operations; Identify and drive continuous improvements to reduce safety risks and costs
Seniority
Manager, hands-on IC with team leadership