- Research & Development
- Denmark - Måløv
Are you looking for new challenges within formulation, process or analytical method development of solid dosage forms and do you want to make a difference? 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 CMC activities for formulation/process development, pilot production, scale-up and analysis of solid protein dosage forms towards clinical trials.
About the department
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 with larger scale. In the later phase the progress towards robust manufacturing processes is of critical importance. The formulation development is done using rational design, statistical and QbD principles.
Overall, you will play a key role in expanding our competency base within the Solid Dosage Form process technology area. This involves providing scientific knowledge for maintaining and building the competencies and technology necessary to go from early research laboratory scale through pilot up-scaling within Solid Dosage Forms. You will be responsible for developing and documenting oral protein formulations and processes for preclinical evaluation and early clinical trials. As part of the process development team, your main task is to set up and report experimental designs to develop oral protein formulations as well as the processes.
More detailed responsibilities include: Drive risk management of projects in the product development team and report risk based scenario results to project core group. Plan and execute project tasks according to a DoE setup. Daily collaboration with technicians, as well as technical supervision in laboratories. Prepare technical protocols and reports and compile technical transfer documents for clinical trial pilot production. Give input to Master Batch Records, IMPDs, and related regulatory documents. Support Pilot production team during GMP production and drive continuous improvements using LEAN/Six Sigma approach.
With your experience from the pharmaceutical industry, you represent the department in multidisciplinary project groups, in which you work closely with experts from a wide range of areas.
The ideal candidate has a PhD in Pharmacy, Engineering, Chemistry or a related field of study and at least 2 years of experience from the pharmaceutical industry. Alternatively, you have a Master’s degree and at least 5 years of experience with formulation and process optimisation of Solid Dosage Forms e.g. within mixing, granulation, compression, coating, or pharmaceutical-technical analyses. Experience with project management is an advantage.
You enjoy working in a dynamic environment, where teamwork is on top of the agenda. As a person, you are known for be structured, and for a high commitment to finding constructive solutions as well as taking responsibility for your assignments. You are able to stay focused in a complex and changing environment.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
For further information please contact Tove Kristiansen Stryhn at +45 3075 3109 or Lone Løgstrup Kimer at +45 3079 3569
11 November 2015