GMP Specialist

4 weken geleden

Hoofddorp, Nederland i-Pharm Consulting Voltijd

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 schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732

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