Senior Scientist – Mechanistic Data Analysis for Oral Delivery

Novo Nordisk A/S

Ballerup, 1 stilling

- Research & Development

- Denmark - Måløv





Are you looking for new challenges within pharmacokinetic and mathematical modelling in relation to drug development of solid dosage forms and do you want to make a difference? Our Oral Protein Formulation Unit (OPF) in Måløv is expanding; therefore we are looking for a dedicated, professional and enthusiastic new colleague. Novo Nordisk is on a voyage towards the development and production of oral formulations of proteins. Our ambition is to develop break-through products based on orally available versions of insulin and GLP-1. You will be involved in 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

We are 34 scientists and technicians in Oral Formulation & Process Development organized in two teams. The Department is overall responsible for development of Solid Dosage Form of Insulin and GLP-1 molecules for oral delivery. The formulation development covers from early phase development of oral protein formulations and processes in small scale to later stages of formulation development in larger scale. The formulation development is done using rational design, statistical design, Quality by Design (QbD) principles and invitro invivo (IVIVC) correlations.



The job

Overall, you will play a key role in building up our competency base within Mechanistic Data Analysis (MDA) and modelling to solve experimental, clinical and theoretical challenges and identify correlations and mechanism of action. All within the preclinical and clinical development of Solid Dosage Form (SDF) formulation and manufacturing technology.



You will be responsible for identifying projects, in which modelling can be used to predict drug product performance, to explain experimental observations and to ensure proper use of the results in regulatory filing documentation. You will be working closely with our formulation scientists and pharmacologists in establishing casual links between data from their respective areas using MDA and IVIVC. You will ensure that the newest developments in modelling and mathematical biology, physiology and chemistry are captured and channelled into relevant projects.



You will ensure that advanced and innovative data analysis methods, which are required to properly describe complex experimental data like pharmacokinetic data, dissolution data and other relevant characterisation data, are applied. The methods will link formulation and characterisation data with clinical data to improve quality and efficiency of drug development. The position also implies a lot of interfaces with many different departments in Novo Nordisk which requires a strong mentality for working independent and being an outspoken person.



With your experience from the pharmaceutical industry, you will represent the department in multidisciplinary project groups, in which you work closely with experts from a wide range of areas.



Qualifications

The ideal candidate has a PhD in engineering, pharmacy, statistical modelling, biology or a related field of study with strong competencies within pharmacokinetics, mathematical modelling, and statistical analyses, and at least 3 years or more of experience within the pharmaceutical industry. Alternatively, you have a Master’s degree and at least 5 years of experience with pharmacokinetic and modelling techniques preferably within in-vitro in-vivo correlation. Strong analytical sense is a trademark for you and you use your high commitment to find constructive solutions. You are a team-player with good presentation and communication skills and known for taking responsibility for your assignments and ability to work across departments. Finally, you must thrive in an environment where ongoing changes are a part of our business’ development.



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 Mette Høg Gaunø at +45 3075 4173, Erik Skibsted at +45 3075 2778 or Lone Løgstrup Kimer at +45 3079 3569.



Deadline

1 November 2015.