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At Kiadis, we are leveraging the natural strengths of humanity and our collective immune systems to source the best cells for life. Our NK cell (natural killer cell) research and development programs and partnerships are at the cutting-edge of the industry, paving the way for new and exciting therapies, in immuno-oncology and beyond.

 

In support of developing our innovative NK cell therapies, we are looking for Senior Quality Control Analyst based in Amsterdam, the Netherlands.

 

The role

As a Senior Quality Control Analyst, you are responsible for a wide range of Quality Control activities and the optimizations of the execution processes. In your day-to-day you will:

  • Perform QC analysis with the generation of In-process control and release test results in accordance with GMP standards and internal processes and procedures.
  • Support the Quality Control lab manager with daily tasks related to lab operation.
  • Advise / Provide support to other internal departments.
  • Generate certificates of analysis for Release testing.
  • Review QC data from testing of product release, IPCs and raw materials.
  • Raise and manage quality incidents, such as deviations, OOS, CAPAs and change controls.
  • Own, review and approve standard operating procedures, work instructions, test methods and other relevant documentation.
  • Design and implement quality control standards.
  • Keep oversight of reagent stocks.
  • Assure proper storage and handling of QC and IPC samples.
  • Assist in documentation related to equipment qualifications.
  • Implementation of appropriate QC lab safety procedures.
  • Support internal and external quality audits and inspections.
  • Drive continuous improvement within the QC lab.

 

Quality

Our Quality department works with a strong motivation to deliver safe and effective personalized medicine to our patients. Our team of highly-skilled professionals ensure compliance on many levels, they also train our employees, which has resulted in quality being a key component of our company culture. As part of the Quality team, you will work with a high sense of urgency, work to continuously improve our processes and collaborate with different people from all over the world. Join us and see for yourself how you can make an impact. 

 

The ideal candidate

We are looking for someone that has a strong background in complex quality control activities for cell therapies. Our ideal candidate meets the following requirements:

  • Education: PhD in a biological discipline preferable.
  • Experience: >5 years in method development and quality control in biotech/pharma industry.
  • Specific skills:
    • Experience in the development of cell-based methods for GMP purposes.
    • Good understanding of analytical variation and complexity and its impact on product quality.
    • Experience in liaising with different departments, such as QA, Manufacturing and Regulatory Affairs.
    • Thorough knowledge of the EU/US and other relevant regulatory requirements.
    • In depth knowledge of ICH guidance’s.
  • Personal characteristics / interpersonal skills:
    • Outstanding interpersonal and communication skills as well as presentation skills.
    • Great project management skills and ability to work well under pressure and with ambiguity.
    • Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision.
    • Ability to manage multiple priorities with aggressive timelines at a high level of productivity.
    • Must be highly organized and possess excellent attention to detail.
  • Fluency in English, other languages are a plus.

 

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within the organization.

 

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have the feeling of belonging & appreciation.