stillingsbetegnelse: Development Scientist – Virology

jobbeskrivelse:
- Research & Development - Denmark - Gentofte The department of Biopharm Purification Development & Virology is seeking a scientist with experience in cell culture based in vitro assays for virus and mycoplasma safety. About the department Biopharm Purification Development & Virology is part of CMC API Development (R&D). The department is responsible for developing, documenting, and transferring scalable purification processes and virus safety for APIs in order to bring the growing pipeline of 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, 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. The Job 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 projects and have the opportunity to develop your scientific and project management skills.You will be a part of a group that ensures virus and mycoplasma safety on biopharmaceuticals in both marketed products and the Biopharm development portfolio. This includes management of cell culture based in vitro quality analyses on production material in addition to a general support function of virus safety. In this, you will contribute to the daily operation of our GMP analysis lab and ensure that we deliver high quality test results in accordance to our timelines.In addition, general maintenance in relation to the analysis will also be an area of responsibility.Furthermore, you will participate in development projects managed in the department. This will include development and validation of in vitro analyses and writing of regulatory documentation with respect to virus safety. Qualifications You hold as a minimum a M.Sc. degree in engineering, human biology, biology, biochemistry or other relevant disciplines.You have a profound experience within cell culture and cell based in vitro assay techniques, including validation and product specific qualification, preferably in accordance with GMP standards. Experience with virus safety evaluation in development of biopharmaceutical processing and production is an advantage. For the ideal candidate, this includes knowledge within the regulatory framework with respect to virus, mycoplasma and TSE. In addition, expertise within molecular detection techniques e.g. qPCR and RT-qPCR is an asset. As a person, you are enthusiastic, open-minded, and a good communicator by nature both orally and written. You are full of initiative with a can-do attitude and are able to work independently as well as in teams. A good sense of humour and ability to keep spirits high in a busy environment is highly valued. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Thomas Carlsen at +45 3079 3422. Deadline 10 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark