stillingsbetegnelse:
Senior Research/Principal Scientist – Modelling Protein Association

jobbeskrivelse:
- Research & Development - Denmark - Måløv Are you looking for new challenges combining protein chemistry, mathematical modelling and pharmacokinetics in relation to drug development? Do you want to break new land and develop the diabetes products of the future? Our Injectable Protein Formulation Unit (IPF) in Måløv, Copenhagen is expanding, therefore we are looking for a dedicated, professional and enthusiastic new colleague. You will be central in our ambition to onset activities to develop and introduce mathematical modelling and statistical analysis as a tool to evaluate pharmacokinetic data, in-vitro data and their correlation into relevant projects in clinical development. About the department You will be part of the department Diabetes Formulation Development within IPF. We are approximately 40 scientists and technicians organized in two teams and a smaller group of Coordinators in Diabetes Formulation Development. The Department is overall responsible for development of injectable formulations for Insulin, GLP-1 and other obesity molecules. The activities cover formulation and process development from early phase in small scale to later stages of development in larger scale. The formulation development is done using rational and statistical design in accordance with Quality by Design (QbD) principles. The job Overall, you will play a key role in: Building up expertise on the link between pharmacokinetics and protein association (protein association covers self-association, association to other proteins in co-formulation and physiological proteins such as albumin); Establishing an understanding of protein association relevant to formulation development of Novo Nordisk diabetes projects; Providing input to the drug product control strategy regarding protein association. Your main tasks will be to: Develop statistical/mathematical models describing the link between protein association and pharmacokinetics; Predict the effect of formulation and process variability/changes on pharmacokinetics and pharmaceutical properties, and apply the results to establish a control strategy for the drug product; Establish an understanding of self-association in equilibria (the species formed) as well as the kinetics for reaching equilibrium, based on data from state-of-the-art analytical methods; Provide input to design of laboratory, non-clinical and clinical studies needed to explore the in-vitro and in-vivo effect of protein association and to obtain data for model development; Establish standards for development projects on activities related to protein association; Increase the general awareness and understanding of protein association within CMC DP Development. You will be a part of development projects, and collaborate with scientists across the organisation. Qualifications The ideal candidate has a PhD in mathematics, physics, pharmacy, engineering or similar field of study with strong competencies as well as practical experience within developing and application of mathematical models. Preferably, you have additional experience within protein association, biosimulation and/or pharmacokinetics. You are also used to working in cross-organizational groups. The position requires a strong ability to approach and connect with people across organisational boundaries, to establish good working relationships and form networks. You must thrive in an independent working environment, demanding self-motivation and a high degree of responsibility for short and long term planning of tasks. We expect that you appreciate professional challenges and complex problems with non-standard solutions. Furthermore you must be ready to act on available data, which may not always be complete, and focused on providing results which are “fit-for-purpose” rather than “perfect”. It is also important that you like to share own expertise and competencies with colleagues in formal as well as informal settings. Good communicati

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