Requirements: English
Company: i-Pharm Consulting
Region: Hoofddorp , North Holland
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 WIs 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 schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732