What will you do as a CAR-T Operations Expert?
As a CAR-T Operations Expert, you will be a specialist in specific parts of the CAR-T production process. Here's what you'll do:
ā Perform and oversee CAR-T process activities: You will participate in and oversee specific parts of the CAR-T manufacturing process such as component preparation, CAR-T processing, filling and finishing, and cryopreservation.Ā Ā
ā Compliance and documentation: You ensure that all activities comply with cGMP and GDP standards. You will develop and maintain GMP documents to ensure compliance and traceability.
ā Operational support: You manage daily production planning and support production surveys. You will create and review operational procedures, including work instructions, master batch records and forms.
ā Collaborate and continuously improve: You will work with various teams to streamline and optimize processes. You will also participate in Lean & Operational Excellence projects.Ā
ā Training: You will train and coach junior colleagues.Ā
ā Technology and systems: You will support the testing and implementation of various software for production output systems such as eLiMS, MES and SAP.