Cell Therapy Operations Associate

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 42,000 - 60,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Cell Therapy Operations Associate to support GMP manufacturing activities in an aseptic cleanroom environment. You will perform production and production-support tasks, including material preparation, batch execution, documentation management, and product handling, ensuring strict cGMP compliance.

Responsibilities include daily manufacturing tasks, media preparation, batch review, sample handling, and collaboration with the Production Support Team for

Qualifications

• GMP manufacturing experience in biotech or pharmaceutical settings.
• Background in Life Sciences is required.
• Experience working in a cleanroom and aseptic manufacturing environment is essential.
• Proficient with data analysis and standard software tools.

Responsibilities

• Perform daily GMP manufacturing tasks in an aseptic environment.
• Assist in batch documentation and timely product release.
• Prepare growth media and materials in cleanroom environments.
• Review batch documentation to ensure accuracy and compliance.
• Prepare, inspect, and cryopreserve final products and samples.
• Transfer samples to QC and manage related documentation.
• Collaborate with Production Support for batch transfer activities.

Skills

GMP manufacturing experience

Life sciences background

Aseptic cleanroom experience

Data analysis

Education

MLO/MBO/HBO in Life Sciences

Tools

Microsoft Word

Excel

Data analysis tools

Job description

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

As a Cell Therapy Operations Associate, you are responsible for supporting GMP manufacturing activities within an aseptic cleanroom environment. You will execute production and production-support operations, including material preparation, batch execution, documentation management, and product handling, while ensuring strict compliance with cGMP regulations, SOPs, and quality standards.

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.

Requirements

• 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.