Company
Our client is an international life sciences organisation operating in a highly regulated environment. They develop and manufacture innovative therapies and are committed to high standards in quality, compliance, and continuous improvement. The working environment is dynamic, fast-paced, and strongly focused on teamwork and operational excellence.
Job Description
For a manufacturing site in Hoofddorp, we are looking for a GMP Cell Therapy Production Specialist to support the production of clinical and commercial cell therapy products in a cleanroom setting. This role sits within either the production team or the production support team and is focused on safe, compliant execution of manufacturing activities, accurate documentation, and proactive support of process improvements.
Responsibilities
The GMP Cell Therapy Production Specialist will be responsible for:
- Executing manufacturing and/or production support activities in a GMP-regulated cleanroom environment (including aseptic areas).
- Following SOPs and cGMP requirements and completing batch records accurately and on time.
- Performing activities such as material preparation, material decontamination, and transferring materials and documentation into cleanroom areas.
- Supporting aseptic processing steps and ensuring consistent process execution to meet quality standards.
- Performing visual inspection activities and supporting cryopreservation activities when required.
- Handling sample submission and coordination with Quality Control / sample management.
- Supporting deviation investigations and contributing to change management activities.
- Troubleshooting basic processing and equipment issues and escalating where needed.
- Identifying opportunities for continuous improvement and supporting implementation of efficiency and quality improvements.
- Working closely with cross-functional teams such as Production Support, Material Management, QA, and QC.
Requirements
- Education at MBO/MLO/HBO level (Level 4+) in Life Sciences or a related discipline.
- Proven experience working in a GMP-regulated pharmaceutical, biotechnology, or similar manufacturing environment.
- Comfortable working in full gowning requirements in an aseptic cleanroom environment.
- Strong attention to detail and confidence with documentation and batch record execution.
- Good skills in Microsoft Word and Excel; comfortable working with data.
- Strong communication skills in English (Dutch is not required).
- A hands-on mindset, willingness to learn, and the ability to adapt in a changing environment.
- Willingness to work in a shift schedule (including weekends).
- Vapro A/B or LITOP A/B is a plus.
Other Information
This role requires working in a cleanroom environment and following strict procedures at all times. Because the work involves blood products, vaccination against Hepatitis B is strongly recommended (candidates should already be vaccinated or be willing to get vaccinated).
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58595
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Ayesha Ullah
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