Virus Clearance Scientist Downstream Development Virology Ledige Stillinger på Novo Nordisk Gentofte
- Virus Clearance Scientist Downstream Development Virology
- Novo Nordisk
- Gentofte D84
- Er åbningsdato
- 15 May, 2019 8 days ago
Novo Nordisk Gentofte presserende behov efter position for Virus Clearance Scientist Downstream Development Virology. Læs denne jobannonce grundigt før ansøger om jobbet. Der er nogle kvalifikationer, erfaringer og kvalifikationsbehov, at arbejdsgiverne kræver. Er din karriere historie passer disse krav? Sørg for at du forstår den rolle, du søger, og at det er egnet til dine evner og kvalifikationer.
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Virus Clearance Scientist Downstream Development Virology Ledige Stillinger på Novo Nordisk Gentofte Detaljer Job:
Are you eager to work with Virology? Are you experienced and motivated to work with protein purification and inactivation of viruses? Do you have an extensive knowledge within virus safety? Then, you could 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. The team is responsible for developing, documenting and transferring scalable purification processes and virus safety for APIs to bring new therapeutic proteins into clinical trials. Moreover, the department ensures high quality adventitious agent analysis with respect to virus and mycoplasma for product release of biopharmaceuticals.
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 interdisciplinary 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.
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 interdisciplinary 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.
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 +2 years relevant experience. In particular, we expect that 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. Ideally, you have also gained 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 also beneficial.
For further information, please contact Kristine Uldahl at +45 3077 5640.
June 11th 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.