Quality Control Scientist (m/w/d) in 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