Formulation Scientist in Solid dosage forms
Formulation Scientist in Solid dosage forms
Novo Nordisk A/S
Ballerup, 1 stilling
- 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 peptides and proteins. Our ambition is to develop break-through products based on orally available versions of insulin and GLP-1. You will be involved in Chemistry, Manufacturing and Controls (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, Oral Drug Product Development is responsible for development of solid dosage forms of insulin and GLP-1 molecules for oral delivery. The formulation development covers early phase development of oral protein formulations and processes in small scale to later stages of large scale formulation development. In the later phase the progress towards robust manufacturing processes is of critical importance. The formulation development is done using rational design, statistical and Quality by Design (QbD) principles.
The position
Overall, you will play a 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 to 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, specialists, managers as well as technical supervision in the laboratories will also be part of your job. You will also be preparing technical protocols and reports plus compile technical transfer documents for clinical trial pilot production. You will provide input to Master Batch Records, IMPDs and related regulatory documents. Supporting the Pilot production team during GMP production and drive continuous improvements using LEAN will be part of your tasks.
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 background in Pharmacy, Engineering, Chemistry or a related field of study and preferably 1-2 years of experience from the pharmaceutical industry. You have experience with formulation and process optimisation of solid dosage forms e.g. within mixing, granulation, compression, coating, or pharmaceutical-technical analyses.
You enjoy working in a dynamic environment, where teamwork is on top of the agenda. As a person, you are known to be structured, and for a high commitment to finding constructive and pragmatic solutions as well as taking responsibility for your assignments. You are able to stay focused in a complex and changing environment.
The position is temporary from 1 September 2016 to 31 October 2017. However, for the right candidate with the right mind-set there will be a good opportunity for permanent employment.
Working at Novo Nordisk
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.
Contact
For further information please contact Trine Skovlund Neerup at +45 3077 5943 or Lone Løgstrup Kimer at +45 3079 3569.
Deadline
15 June 2016.
