Senior Scientist for outsourcing of Clinical Bioanalysis

Senior Scientist for outsourcing of Clinical Bioanalysis

• Research
• Denmark - Måløv

The department of Development Bioanalysis is seeking a highly qualified and motivated scientist to support the outsourced non-clinical and clinical 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).

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. We are working in a GLP regulated environment and in-house we use Watson LIMS 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 and is located in Måløv.

The position
Your task will be to support the outsourced clinical bioanalysis projects. Furthermore, the job could include developing and validating drug specific LC-MS/MS methods according to current guidelines and analysis of non-clinical and clinical study samples.

Knowledge of immunoassay (e.g. ELISA and AlphaLISA) is preferred. 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 analysis at CROs but the job could also include in-house analysis. The support to the CRO work is 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 experience and have a minimum of 3 year of experience with development and validation of bioanalytical methods using LC-MS/MS and preferably also immunoassays (ELISA and/or AlphaLISA). You are familiar with EMA/FDA/OECD guidelines and have a quality mind-set. 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.

Working at Novo Nordisk
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.

Deadline
23 August 2017.

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