stillingsbetegnelse:
Senior Research Scientist - Chromatographic Method Development

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 Chemistry Manufacturing Control Development(CMC) Diabetes Analytical Development in Måløv, Copenhagen. About the department The Injectable Analytical Development Department is part of Chemistry Manufacturing Control Development (CMC) Injectable Protein Formulation. The department is organised into three teams with a total of 38 highly skilled technicians and scientists. The position is in the team Injectable Method Development, which consists of 6 scientists and 5 technicians. Acting as the link between research unit and production the team is responsible for developing and documenting analytical methods for new diabetes products. The team supports projects from early development to phase 3 clinical trials and registration. The analytical platform consists mainly of the chromatographic methods High Pressure Liquid Chromatography(HPLC) and Ultra Pressure Liquid Chromatograph(UPLC). The position Your main focus will be to develop analytical methods within Ultra Pressure Liquid Chromatography(UPLC) and High Pressure Liquid Chromatography(HPLC) techniques in order to support development of drug substances and drug products for next generation diabetes treatment. The analytical development discipline includes generation of relevant regulatory documentation, method validation and characterization support. Furthermore you will act as PI (Principal Investigator) in Good Laboratory Practice (GLP) studies, supporting the non-clinical development with analytical results and reports.You will be working on several diabetes projects in close collaboration with our many stakeholders e.g. Research Unit and Drug Product Formulation 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 is not a requirement. You have a minimum of 5 years practical experience within High Pressure Liquid Chromatography(HPLC)/Ultra Pressure Liquid Chromatography(UPLC) analytical development in the pharmaceutical industry. You have an intrest and experience within Good Laboratory Practice(GLP) (dose formulation analysis) and the non-clinical area. You have a good knowledge of general protein chemistry, High Pressure Liquid Chromatography(HPLC)/Ultra Pressure Liquid Chromatography(UPLC) and validation. Knowledge of Good Manufacturing Practice(GMP)/Good Laboratory Practice(GLP) regulatory requirements is an asset. Analytical method development is based on quality by design tools such as Design of Experiments and Mathematical Modelling. A sound knowledge and theoretical understanding of these tools are advantageous.You have a positive and flexible mind-set, which is helpful in a changing project environment and further allows you to build close relations to colleagues and stakeholders. You drive projects independently, and consistently ensure timely and high quality deliverables. You must be a team player that is driven by reaching goals in collaboration with your colleagues. 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 Mille Kolind at +45 3079 5653. Deadline 29 April 2016

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark