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Quality Control Scientist (m/w/d) in Langenfeld, Deutschland

Catalent

Langenfeld, Deutschland

Catalent seeks a Quality Control Scientist for its Langenfeld facility, which develops cell therapies based on induced pluripotent stem cells (iPS-cells) in a GMP environment. The role involves conducting quality control analyses, batch testing, and GMP documentation to support the manufacture and release of advanced therapy medicinal products.

Responsibilities

  • Perform quality control and analytical testing in GMP-regulated settings
  • Conduct analytical, microbiological, and cell culture-based assays for iPS-cell derived product manufacturing and release
  • Execute batch testing, sample processing, and coordinate external analyses
  • Create, maintain, and revise GMP-relevant documents including SOPs and reports
  • Support method validations, equipment qualifications, and quality investigations

Requirements

  • Degree in biology, biotechnology, pharmacy, microbiology, biochemistry, or related natural sciences
  • Professional experience in quality control, analytics, or GMP-regulated environments
  • Knowledge of GMP requirements and pharmaceutical quality and documentation standards
  • Experience with cell culture techniques and familiarity with ATMPs or stem cell characterization
  • Proficiency in German and English languages
  • Structured, quality-oriented work approach with strong teamwork and responsibility
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