stillingsbetegnelse: Clinical Bioanalysis Scientist

jobbeskrivelse:
- Research Scientist - Denmark - Måløv The LCMS Bioanalysis team in the Department of Development Bioanalysis is seeking a highly qualified and motivated scientist to primarily support the outsourced clinical diabetes projects. We are developing, validating and using LC-MS/MS and immunoassay bioanalytical methods for quantitative measurement of drugs and excipients in samples from non-clinical and clinical studies. The assays are performed both in-house and at Contract Research Organisations (CROs). The position is a temporary position for 19 months until 28-Feb-2017. About the department The department is responsible for bioanalysis for non-clinical and clinical safety and efficacy evaluations across the entire project portfolio at Novo Nordisk A/S. We are working in a GLP regulated environment and in-house we use WatsonLIMS for collection of data and reporting. The department is part of the Non Clinical Development (NCD) area in the Global Research Unit of Novo Nordisk A/S, and is located in Maaloev. The job Your main focus will be to support the outsourced clinical bioanalysis projects. Furthermore the job could include developing and validating drug specific LC-MS/MS and/or immunoassay (ELISA) bioanalytical methods according to current guidelines and analysis of non-clinical and clinical study samples. You will represent the Development Bioanalysis Department in cross functional project teams and be responsible for collaboration and timely delivery of bioanalytical data to stakeholders. You will primarily be responsible for analyses at CROs but the job could also include in-house analysis. The support to the CRO work is will performed by reviewing their study plans, reports and eventually visiting them for troubleshooting and/or review of raw data . Hence, a number of travel days per year must be expected. Qualifications You hold a life science academic PhD degree or similar experince and have a minimum of 3 years of experience with development and validation of bioanalytical methods (LC-MS/MS and/or immunoassays (ELISA and/or AlphaLISA)). Preferably, you are familiar with EMA/FDA/OECD guidelines and have a quality mindset. Flair for use of IT-systems will be appreciated. You have strong written and oral communication skills in English as well as the capability to work in an interdisciplinary environment. You are flexible, ambitious, focused on results and have a good sense of humour. You are good at communicating and collaborating in teams. You will join a team in a highly dynamic and challenging environment within the Development Bioanalysis Department. At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact For further information, please contact Sune Hove Sporring at +45 3079 4905 or Michael Pilgaard Andersen at +45 3075 4819. Deadline 9 August 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Undervisning og forskning på universiteter og højere læreranstalter

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark