Virus Clearance Scientist within Stem Cell Development

Novo Nordisk A/S





Gentofte, Capital Region of Denmark, DK

Are you eager to work with Virology? Do you want to play a significant role in driving virus safety standards for novel treatment concepts such as Stem Cells for Diabetes and Parkinson’s Disease? Then this position might prove the right challenge for you. You will be part of an expert team to develop virus safety strategies for cutting edge stem cell therapies.

About the team
The Virology team is part of Downstream Development in the CMC API Development (R&D) organisation, that brings new therapeutic products into clinical trials. The department is responsible for developing, documenting and transferring scalable purification processes, and the virus team assures the viral safety of these processes. Moreover, the team ensures high quality adventitious agent analysis with respect to virus and mycoplasma for product release of biopharmaceuticals.

Recently, we are growing our competencies within mycoplasma and virus safety of Stem Cell therapies to support the newly established Stem Cell R&D unit in Novo Nordisk.

We emphasize a scientific approach in our work that is performed in multidisciplinary project groups in close collaboration with analytical- and process development, our US-production facility, the quality departments as well as international contract organizations. Thus, a wide interdisciplinary understanding of the development process for biopharmaceuticals and ATMPs is needed to support decision making and progress within this area. The working climate is informal with a high degree of flexibility.

The position
As a virus clearance scientist, you will work closely with other experts to develop and manage virus clearance safety strategies for Stem Cell research projects. You will provide guidance on virus safety with respect to drug development with all its interdependencies and regulatory challenges. A main task will be the establishment of virus barriers on raw materials either at the vendor or in house by implementing appropriate virus inactivation or removal measures. You will contribute to cross-disciplinary project teams as a virus safety expert, and the position offers the opportunity to develop your scientific and project management skills.

You will contribute to the daily coordination of our virus clearance lab and ensure that we deliver high quality results in accordance with our timelines. In addition, you will be involved in cell bank testing, raw material virus risk evaluations and other aspects of adventitious agent safety evaluation of biopharmaceuticals and ATMPs.

Furthermore, you will participate in development projects managed in the department. This will include design and development of purification processes with a virus clearance perspective in collaboration with purification scientists.

You hold as a minimum a M.Sc. degree in chemical engineering, biochemistry, cell biology, or other relevant discipline combined with 3-5 years relevant experience or a PhD within a relevant area +2 years relevant experience.

You have experience with cell work in pilot or production scale, and an understanding of assays for the detection of viruses. Experience with virus safety evaluation of biopharmaceuticals/ATMPs is an advantage, as well as knowledge within relevant regulatory guidelines, such as ICH Q5A.

The ideal candidate has experience within the regulatory framework of virus, mycoplasma and TSE.

We operate in a fast-changing environment, with an increasing level of automation and digitalization. It is therefore considered an advantage to be an innovative individual with ability and experience within the areas of automation and digitalization. Expertise within NAT-based technologies, e.g. qPCR, RT-qPCR and NGS, is beneficial.

For further information, please contact Christian Kjærulff Mathiesen at +45 3075 4658

November 05th 2019

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

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Ansøgningsfrist d. 05.11.2019
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Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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