stillingsbetegnelse:
Formulation and Process Scientist - Solid Dosage Forms

jobbeskrivelse:
- Research & Development - Denmark - Måløv 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. Positive Phase II results have recently been obtained and that is why we are looking for new colleagues to support and work with our oral formulation portfolio. So if you have experience with process development, up-scaling or formulation development within solid dosage form and the different disciplines, you might be one of our new colleagues About the department We are 40 scientists and technicians in Oral Formulation & Process Development organized in tree teams. The Department is overall responsible for development of Solid Dosage Forms 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. The job Overall, you will play a key role in expanding our competency base within the Solid Dosage Form process or formulation technology area. This involves providing scientific knowledge to carry the product from laboratory scale through pilot up-scaling within Solid Dosage Forms. You will be responsible for developing and documenting oral protein formulations and processes for clinical trials and launch to market. As part of the Process Support team, your main task lies within formulation development, process design, troubleshooting and validation. More detailed responsibilities can include: Process and drug product responsibility, development of up-scale production process, preparation of filing documentation, deviation management, process optimisations, plan and execute project tasks according to a QBD setup. You will have daily collaboration with technicians, as well as technical supervision in laboratories and pilot production. 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. Qualifications The ideal candidate, has a PhD in Pharmacy, Engineering, Chemistry or a related field of study and at least 5 years of experience from the pharmaceutical industry. Alternatively, you have a Master’s degree and at least 5 years of experience with the 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 at the top of the agenda. As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments. 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 Peter Langkilde Sonne at +45 3079 8415 or Marie Beck Nellemann at +45 3075 8032. Deadline 12 April 2015.

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