Associate, Patient Materials Operations, MSS
Core
Managing patient material needs and logistics for CAR-T cell therapy production in controlled environments.
Role type
Associate, Patient Materials Operations (Cell Therapy Manufacturing)
Builds
CAR-T cell therapy products for patients
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, SOP execution, apheresis handling, batch record execution, deviation investigation, CAPA closure, logistics coordination, problem solving
Preferred skills
Bioprocessing experience, degree in relevant field
Technologies
LIMS, Electronic Batch Records, Courier systems
Responsibilities
Perform tasks for Cell Therapy products to support product Value Stream outputs according to cGMPs; Maintain timing according to the production schedule; Perform apheresis receipt of patient materials and prepare final product shipments; Execute receipt and discard of ex-US PBMC and CMAT; Support Sample Retrieval, Movements, and Storage; Support transfers of Manufactured Goods to off-site facility; Support manual and electronic batch record executions and closure of CAPAs.
Seniority
Entry-level (0-1 years experience)