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Senior Scientist Quality Control

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15 JAN '23: For an organisation located in Leiden, equipped with cutting-edge facilities and specialised expertise in the creation, manufacturing, and marketing of Cell and Gene Therapies, we are actively seeking a Senior Scientist in Quality Control. This role supports academic and industrial developers in progressing to clinical trials by providing essential expertise within a newly established development and GMP manufacturing center.

Details

Biotechnical

Quality/RA

Leiden - Netherlands

40 uur per week

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Zo maak jij het verschil

The Senior Scientist for Quality Control will lead the microbiological testing strategy, encompassing environmental monitoring and data analysis. As the subject matter expert, your role includes overseeing the transfer and validation of assays, managing in-process and final product release tests for cell and gene therapies, aligned with GMP standards. Your duties involve authoring QC-related documentation, conducting risk assessments, and working collaboratively across departments. Additionally, you will supervise the Environmental Monitoring Technicians and the team of Microbiological and Physicochemical Scientists.

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Wat jij mee brengt

We are looking for a Senior Scientist Quality Control with:


  • MSc. or higher degree in a relevant field (biology, Microbiology, biotechnology or similar);
  • At least 5 years of relevant work experience in a GMP compliant industrial setting;
  • Knowledge of GMP requirements for sterile biologics and-assays;
  • Experience with Advanced Therapy Medicinal Products will be advantageous;
  • Experience with working in quality control and assay development in a biotech environment;
  • Experience with various test techniques, for example microbial (endotoxin, bioburden, sterility, mycoplasma), EP testing, microbial culturing, , cell-based assays, etc;
  • Experienced in writing SOP’s and other GMP Documents e.g. test records, qualification/validation documents, specifications, etc.;
  • Hands-on experience with the relevant assays.
     

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Jouw voordelen

Our client places high importance on employee comfort and workplace satisfaction. They provide a contemporary and vibrant work setting that fosters teamwork within a flat structured organisation, ensuring swift and efficient communication and excellent job terms. As an early member of the team, you'll have a pivotal role in shaping the company's future and advancing its founding mission. The employment package includes:


  • Competitive salary;
  • 8% bonus for holidays;
  • Permanent 13th-month;
  • 25 vacation days for a 36-hour work week;
  • Travel compensation starting at 10 km at €0.21 per km, with full public transport costs covered;
  • Non-contributory pension plan.

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