stillingsbetegnelse:
Senior Analytical Coordinator (Project Management)

jobbeskrivelse:
- 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? Our Oral Protein Formulation Unit (OPF) in Måløv is expanding therefore we are looking for several dedicated, professional and enthusiastic new colleagues. 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 Oral Analytical Development is part of Oral Protein Formulation in the R&D area CMC Development. The department is organised into three teams with a total of 50 highly skilled project managers, specialists, scientists and technicians. Acting as the link between the research unit and the production the department is responsible for developing analytical methods for new oral diabetes products – all the way from early development to phase 3 clinical trials and registration. The job We are looking for an experienced project manager – an analytical coordinator - to coordinate our oral phase 3 project. You will be part of the departmental team of 4 analytical coordinators, and will work in close collaboration with scientists from other departments.As analytical coordinator you will be a member of the CMC core project team along with other CMC technical coordinators, and will interact with a wide variety of stakeholders, e.g. drug product development, API process development, quality assurance and regulatory affairs. In this role you will be responsible for aligning the needs of the project organisation with those of line of business. Close collaboration with the line management of the departments are vital in order to ensure the most optimal planning and execution of project targets. More detailed responsibilities include: Breakdown of project key deliverables to department activities in our primary project planning system. Plan the timing of department activities together with team leaders, team members and other project coordinators. Clearly and timely communicate project requirements to team- and department members. Prepare and coordinate regulatory documentation according to international guidelines. Qualifications The person we are looking for has 3-5 years of experience in managing CMC activities covering early phase to late phase clinical development. Detailed knowledge of the pharmaceutical value chain is a must as well as excellent knowledge of the CMC documentation flow and work processes, including some experience with GMP.Scientific experience within analytical development is a great advantage for the candidate. A MSc or PhD education level in a relevant scientific field is compulsory in order to become a successful applicant for the position.As a person we expect you to have excellent collaboration skills, be structured and reliable and to have an ability to stay calm and make the right decisions in a dynamic work environment. Also, you are a team player and have a feel for communicating essential information to the right stakeholders at the right time. At Novo Nordisk we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous scientific challenges. Contact For further information, please contact Birthe Ross at +45 3075 2831. Deadline 26 February 2016.

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