Senior Expert Science

3 weken geleden

Amsterdam, Noord-Holland, Nederland Novartis Voltijd

10 days, that is how long we treat a patient's T-cells, before we return them to potentially save this patient's life.

To support such novel, personalized treatment by defining and implementing the microbial control strategy, is a unique challenge within Novartis with immediate patient impact.

As a member of the Technical Development group, this individual will manage and own current and future Cell and Gene development projects and contribute to interdisciplinary technical development work in the larger CGT organization.

The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write protocols, reports, and other source documents for regulatory submissions.

Contribute to risk analyses and/or peer review and process challenge meetings.

Your responsibilities will include, but are not limited to:

  • Provide scientific/technical leadership for developing, optimizing and validating efficient and robust processes to manufacture cell-based therapeutics.
  • Perform experimental design, protocol development and execution, data analysis, technical report writing and presentation.
  • Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.
  • Collaborate with cross-functional teams, including analytical, quality assurance, technical operations and regulatory to establish robust manufacturing processes that comply with GMP and regulatory requirements
  • Contribute to technology transfer, comparability, process characterization, process validation and troubleshooting
  • Contribute to Quality risk management assessment and mitigation efforts to meet Quality target Product Profile (QTPP) and Target Product Profile (TPP)
  • Define process operating ranges, acceptable ranges for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA)
  • Deliver on project milestones, including technical presentations, development reports and other documents relevant to GMP operations.
  • Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standard
  • Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented. Contributes to management decision making and advisory boards. Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call and let us know the nature of your request and your

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