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GMP scientist USP

• Working in a new high-end Commercial Manufacting Facility
• Working for one of the fastest growing biotech companies of Europe
• This CDMO got an investment of 200 million Euros

• Setting up clinical and large scale mammalian cell culture processes for the production of recombinant medicinal products, including mAbs, viral vectors, and vaccines.
• Supporting technical transfer assessments, facility fit, bioreactor processes, media, cell culture scale-up, and clarification (harvest).
• Leading hands-on problem-solving efforts and root cause investigations to resolve deviations related to equipment, processes, or products.
• Presenting process data and project updates to clients.
• Preparing protocols, reports, process flow diagrams, and manufacturing batch records.
• Providing onsite technical support for manufacturing scale processes.
• Demonstrating a strong focus on continuous improvement, identifying and completing improvement projects.

• Bachelor's or Master's degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry).
• 7+ years of work experience in upstream process support and development, with preferred experience in a biological safety environment.
• Knowledge of FDA/EMA regulatory requirements applicable to biologics.
• Ability to apply GMP regulations and international guidelines.
• Excellent problem-solving, critical thinking, writing, communication, and presentation skills.
• Ability to analyze and summarize complex scientific data.
• Excellent organization, planning, and time management skill

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