GMP scientist USP Leiden

1 maand geleden

Leiden, Nederland Talent Associates Voltijd
  • 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

In summary, we specialize in streamlining the path from drug discovery to clinical application. Beyond that, we utilize our skilled team, expansive global network, and diverse range of services to tailor the most effective journey for our clients, all with a steadfast dedication to the ultimate goal: the patient. Currently, we're seeking a USP Scientist GMP for our new Manufacturing Facility.

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.

Your profile

  • 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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