Virus Clearance Scientist: Cross-disciplinary position within Downstream Development

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Gentofte

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  • Gentofte

Are you eager to work with Virology? Are you experienced with and motivated to work with protein purification and inactivation of viruses? If you also have an extensive knowledge within virus safety, then you may be our new Virus Clearance Scientist.

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, production, and quality departments as well as international contract organizations. Thus, a wide cross-disciplinary understanding of the development process for biopharmaceuticals is needed to support decision making and progress within this area. The working climate is informal with a high degree of flexibility.

The position

We offer a position in which you will be able to develop your knowledge of virus safety with respect to drug development with all its interdependencies and regulatory challenges. You will contribute to cross-disciplinary project teams and have the opportunity to develop your scientific and project management skills.

You will be part of a team that ensures virus and mycoplasma safety of biopharmaceuticals in both marketed products and the development portfolio. This includes being a GLP study director on virus clearance evaluation studies to assess the capability of the overall purification process to remove and/or inactivate viruses. In this, 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 evaluations and other aspects of adventitious agent safety evaluation of biopharmaceuticals.

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.

Qualifications

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

You have experience with protein purification at laboratory, pilot or production scale, and an understanding of assays for the detection of viruses. Experience with virus safety evaluation of biopharmaceuticals 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 molecular detection techniques e.g. qPCR and RT-qPCR and NGS is beneficial.

Contact

For further information, please contact Anne Charlotte Arentsen at +45 3075 9242

Deadline

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.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Gentofte.

Jobbet er oprettet på vores service den 11.10.2019, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • Gentofte
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