Cell Therapy Specialist, Hoofddorp, Noord-Holland

The Company
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.

Role Description
The Cell Therapy Specialist supports GMP manufacturing activities within an aseptic cleanroom environment. The role involves executing production and production-support operations, including material preparation, batch execution, documentation management, and product handling, while ensuring strict compliance with cGMP regulations and standard operating procedures (SOPs).

Responsibilities

• Perform daily operational tasks within the manufacturing process, including the transfer and handling of blood products and cell samples.
• Support the preparation of growth media and other materials in cleanroom environments.
• Assist in reviewing batch documentation to ensure accurate and timely product release.
• Conduct material decontamination and supply manufacturing suites with required components.
• Prepare, inspect, and cryopreserve final products and excess cells.
• Transfer samples to QC for testing and manage sample documentation.
• Collaborate with the Production Support Team to perform tasks such as apheresis accession and batch transfer.

• Qualified in MLO, MBO, HBO (MBO level or higher) with a background in Life Sciences.
• Experience working in GMP pharmaceutical or biotech manufacturing is essential.
• Knowledge of pharmaceutical manufacturing processes for biotechnology products.
• Familiar with cleaning and sterilization procedures such as Vapro A and B or LITOP A and B is a plus.
• Skilled in Microsoft Word, Excel, and data analysis tools.
• Comfortable working in full gowning aseptic environments and adhering to strict GMP protocols.

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