stillingsbetegnelse: Principal Investigator for GLP Studies

jobbeskrivelse:
- Research & Development - Denmark - Måløv Do you have the knowledge to contribute to the development of the 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 and Control (CMC) Injectable Analytical Development in Måløv, Copenhagen. About the department The Department Injectable Analytical Development is a part of CMC Injectable Protein Formulation in R&D. The department is organised in 4 analytical teams. The department is responsible for developing analytical methods and delivering analytical results for new products - acting as the link between the research unit and the production, all the way from early development to phase 3 clinical trials and registration. Our analytical platform consists mainly of chromatographic methods, HPLC and UPLC. The position You will join the GLP team and act as a Principal Investigator (PI) responsible for chromatographic analysis of Dose Formulation samples from non-clinical studies in accordance with the principles of Good Laboratory Practice (GLP). Your main focus will be ensuring that the non-clinical studies receive analytical results, at the right time and in the right quality. This includes giving input to study plans and writing reports, generating relevant documentation, validating analytical methods as well as stability, robustness and characterization support. You will work on several GLP projects/studies in close cooperation with Non-Clinical Development (NCD) and Quality Assurance (QA) in connection with non-clinical safety evaluation in the development of drugs and medical devices, in support of clinical research and/or marketing applications. Qualifications You hold a Master degree within Life Sciences (Pharmacy, Biochemistry, Engineering or other relevant discipline). A PhD or similar experience is an advantage but is not a requirement. You have practical experience within HPLC/UPLC analytical development preferable within in the pharmaceutical industry. You have a good knowledge of general protein chemistry, HPLC/UPLC and validation. Knowledge of the GLP principles is an asset. Analytical development is based upon several QbD tools, e.g. Design of Experiments and Mathematical Modelling and knowledge hereof is thus an advantage. As person you have a positive and flexible mind-set, which is helpful in an ever changing project environment. You have excellent interpersonal skills that allow you to build fruitful relations to both colleagues and stakeholders. You are a team player and contribute to reaching team goals. You have excellent oral and written communication skills, including proficiency in English. Working at Novo Nordisk 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 Martin Mørch Hansen at +45 3075 0008. Deadline 7 June 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