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Novo Nordisk

Project Manager in CMC Development, Cell Therapy

Fuldtid

Permanent

Novo Nordisk Park 1, 2760 Måløv, Danmark

SE PÅ KORT
ID: 2741730
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Indrykket for 1 dage siden

Do you want to take part in creating the therapies of the future? Do you want to support the development of a hES/iPS cell engineering platform within the Cell Therapy R&D unit at Novo Nordisk? If yes, then apply today and come support us in translating stem cell-derived cell therapies into the clinic!

The position
In this role you will have the possibility to make a difference, making path to the cure. Your daily tasks will cover coordination of all tasks in the Hypoimmune project towards research and GMP manufacturing. You will help setting the overall strategy for the project and set direction for the CMC Development part of the project. You will be part of a dynamic team that together translate proof of concept studies from our cell engineering colleagues in research into robust high efficiency manufacturing processes fit for our GMP production site in Fremont, California. The protocols and processes overseen by you in your role as Project Manager will play a crucial role in supplying the Cell Therapy R&D unit pipeline with cutting-edge next-generation cell therapies. These therapies include genome-modified hypoimmunogenic allogeneic cell therapy products designed for the treatment of type 1 diabetes, chronic heart failure, and Parkinson’s disease, positioning us at the forefront of innovation in these therapeutic areas.

You will be part of a unique, innovative and collaborative culture in Cell Therapy R&D, where you will work as part of a dedicated and supportive team, and with a high degree of autonomy and empowerment in your daily tasks. 

This position requires flexibility to work across time zones with colleagues sitting in Denmark and California, US. The role has limited travel activity.

Qualifications
We are looking for a Project Manager with the ability to rapidly get the overview of a complex project and who can go into details whenever this is needed. You should have experience and passion for mammalian 2D (stem) cell culture. It would be advantageous if you also have cell electroporation, flowcytometry-based cell sorting and single cell cloning experience.

We expect you to preferentially have the following competencies: 

  • Master’s degree or PhD in relevant scientific field.
  • 3 plus years’ project management experience, including risk management and project communication.
  • Have a profound knowledge of GMP and production in the pharmaceutical industry. 
  • Experience in gene editing and development, and application of biological methods such as gene sequencing or clone screening.
  • Experience in process development.
  • Experience with cell culture of human/mammalian cell lines, in particular human pluripotent stem cells.
  • High proficiency in spoken and written English.
  • On a personal level, you are dedicated, flexible and with great project management skills. You are resilient and have a can-do attitude. In addition, you have the ability to work in a team-oriented and multidisciplinary as well as multicultural environment. 

    About the department
    2D Process Development in CMC Development is a dynamic, technology driven department working in close collaboration with our neighboring Research department, our Fremont GMP Production site, Raw Materials and regulatory experts among others. We are part of Cell Therapy R&D, a Transformational Research Unit (TRU) within Novo Nordisk. The TRU is unique in the sense that it covers the full R&D value chain, which means we function as an integrated unit, spanning from early research to GMP manufacturing and clinical development in the same organization. Our department is part of the CMC organization based in Måløv, Denmark and we are experts in translating research protocols into manufacturable gene editing-based stem cell products.

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