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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
Responsibilities
- 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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