i-Pharm Consulting

GMP Specialist – Cell Therapy

Job Location

Nederland, Netherlands

Job Description

Job Title: GMP Specialist – Cell Therapy Contract Duration: 12 Months Location: Netherlands, Hoofddorp (On Site) Shift: Rotational (Morning/Evening Shifts, including Weekends) Our client is looking for highly motivated and hands-on individuals to join their Production Support Team and Production Team in their Manufacturing Department. As a leading innovator in cell therapy, they are dedicated to developing cutting-edge treatments that have the potential to transform the lives of patients. This is a unique opportunity to be directly involved in the manufacturing of both clinical and commercial products that make a meaningful impact on healthcare worldwide. Key Responsibilities: Production Support Team Perform apheresis accession and transfer to manufacturing areas. Prepare growth media in cleanroom ‘nest’ environments. Support review of batch documentation to ensure timely release. Decontaminate materials before delivering them to manufacturing suites. Transfer and submit samples to QC sample management. Provide materials and components to support the manufacturing process. Perform visual inspection of final products and manage cryopreservation of excess cells. Production Team Execute GMP runs in A and B grade cleanrooms, following batch records and SOPs. Collaborate with cross-functional teams (Product Sciences, QA, QC) to ensure successful manufacturing outcomes. Draft and revise manufacturing Batch records, SOPs, and WI’s to support process improvements and maintain compliance. Troubleshoot processing and equipment issues. Adhere to SOPs and cGMP regulations to ensure high-quality output. Maintain cleanroom environments in optimal conditions. Contribute to deviation investigations and support change management initiatives. Requirements Education: MLO/MBO/HBO (MBO Level ) in Life Sciences or a related field. Prior cGMP experience in a pharmaceutical/biotechnology manufacturing environment is required. Knowledge of pharmaceutical manufacturing processes for biotechnology products. Experience working in a cleanroom and aseptic environment is essential. Excellent communication skills (verbal and written in English.) Additional Information: This role requires flexibility with a shift schedule, including weekend work. If you're looking for an opportunity to make a meaningful impact in the field of cell therapy and grow within a dynamic and innovative environment, we encourage you to apply If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratnai-pharmconsulting.com or call: 44 (0) 2075510732

Location: Nederland, NL

Posted Date: 4/19/2025
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i-Pharm Consulting

Posted

April 19, 2025
UID: 5102021070

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