stillingsbetegnelse: Temp. Research Scientist

jobbeskrivelse:
- Research Scientist - Denmark - Måløv Do you have the knowledge to contribute to the development of the diabetes products of the future? And do you enjoy working in an open, dynamic and social atmosphere with a strong focus on technical and scientific skills? If so, you have the opportunity to play a key role in CMC Diabetes Analytical Development in Måløv, Copenhagen. About the department Department Diabetes Analytical Development is a part of CMC Injectable Protein Formulation in R&D. The department are organised in three analytical teams with a total number of 44 persons. The open temporary position is in team Diabetes Method Development, which consists of 8 scientists and 6 technicians. Acting as the link between the research unit and the production the department is responsible for developing analytical methods for new diabetes products – all the way from early development to phase 3 clinical trials and registration. The analytical platform consists mainly of chromatographic methods, HPLC and UPLC. The job Your main focus will be to develop analytical methods within UPLC and HPLC techniques in order to support development of drug substances and drug products for next generation of products for diabetes treatment. The analytical development discipline includes generation of relevant documentation, validation, robustness, stability, characterization support and regulatory documentation. You will also act as PI (principal investigator) in GLP studies, supporting the non-clinical development with analytical results and reports. You will work in a series of diabetes projects in close cooperation with the Research Unit, Formulation Development, Upstream and Downstream API Process Development, Product Supply, Structural Characterization, non-clinical Development, Quality and Regulatory Affairs. Together with your colleagues you will contribute to the on-going optimisation of processes and systems using LEAN. Qualifications You hold a Master’s degree within Life Sciences (Pharmacy, Engineering or other relevant discipline). A PhD or similar experience could be an advantage but not a requirement. You have practical experience within HPLC/UPLC analytical development preferrable within in the pharmaceutical industry. You have a good knowledge of general protein chemistry, HPLC/UPLC and validation. Knowledge of GMP/GLP regulatory requirements is an asset. Analytical development is based upon several QbD tools, e.g. Design of Experiments and Mathematical Modelling. Therefore, knowledge hereof is an advantage. As person you have a positive and flexible mind-set, which is helpful in an ever changing project environment and enabling you to build fruitful relations to colleagues and stakeholders. You are a team player and contribute to reaching team goals. You have excellent oral and written communication skills. 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 David Nolan at +45 3075 6398, or Mette Willer Oldenborg at +45 3075 1662. Deadline 3 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark