Manager, MSAT Validation & LCM
Core
Lead process validation and Lifecycle Management for a new Cell Therapy manufacturing facility, ensuring cGMP compliance and operational efficiency.
Role type
Manager, Process Validation & Lifecycle Management (Cell Therapy)
Builds
Commercial manufacturing capabilities for personalized cell therapy treatments
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Required skills
cGMP compliance, process validation, aseptic process simulation, lifecycle management, risk assessment, data analysis, change control, audit readiness
Preferred skills
Advanced degree in science/engineering/biochemistry, experience with health authority audits
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, qualification and validation; Lead/Own site Change Controls; Participate in facility and process risk assessments; Ensure safe and compliant cGMP operations and inspection readiness; Drive continuous improvements to reduce safety risks and operational costs
Seniority
Manager, hands-on IC with team leadership