Senior Specialist, MSAT Validation & LCM
Core
Provides process validation and Lifecycle Management support for the Leiden Cell Therapy Facility, ensuring safe and compliant cGMP operations for commercial manufacturing of cell therapies.
Role type
Senior Specialist, Process Validation & Lifecycle Management (Cell Therapy Manufacturing)
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 (specifically: facility, process, and aseptic validation activities; process tech transfers; implementation of product lifecycle changes; equipment and facility commissioning, qualification and validation; change controls; investigations)
Required skills
cGMP compliance, multi-national biopharmaceutical/cell therapy regulations, facility/clean room design, process validation, aseptic process simulations (APS/APV), process performance qualifications (PPQ), data analysis and statistics, risk mitigation (root cause analysis, CAPAs), change control management, audit support (pre-licensure inspections), regulatory inspection readiness
Preferred skills
Advanced degree in science, engineering, biochemistry or related discipline
Technologies
None explicitly listed beyond general process/equipment/automation
Responsibilities
Execute Aseptic Process Simulations/Validations (APS/APV) and Process Performance Qualifications (PPQ); Design and execute test plans for investigations; Lead site Change Controls; Interface with process engineers as validation SME; Support equipment and facility commissioning and qualification; Participate in facility and process risk assessments; Support continuous improvements to reduce safety risks and operational costs
Seniority
Senior, hands-on IC
