Arbejde Drug Product Coordinator - Project Management Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Drug Product Coordinator - Project Management

jobbeskrivelse:
- Research & Development - Denmark - Måløv Are you an experienced Project Manager ready for new challenges? Our department is dedicated to developing the next generation of proteins for the treatment of Diabetes and Obesity. We are involved in projects throughout the clinical phases and registration. So if you want to be part of the journey please keep reading! About the department You will join our team called Diabetes Formulation Development in CMC Supply, being a part of the R&D organisation. We are organised in three teams with a total of 40 highly skilled project leaders, specialists, scientists and technicians. We are responsible for developing formulations and production processes for injectables formulations of new therapeutic proteins and peptides. We are involved in development and research projects within Diabetes and Obesity. The job We are looking for an experienced project manager – a drug product coordinator - to coordinate projects within the Diabetes portfolio. You will be part of the departmental team of 6 drug product coordinators, and will work in close collaboration with scientists and technicians in order to make things happen. As drug product 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. analytical development, production pilot plant, 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 is 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. Communicate risk based development and pilot manufacture scenarios to the CMC core project team. Clearly and timely communicate project requirements to team- and department members. Prepare and coordinate regulatory documentation according to international guidelines. Drive continuous improvements using a LEAN/Six Sigma approach. 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 with drug development and manufacture is a great advantage for the candidate as is knowledge in protein analysis and formulation. An 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 keep your cool 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 either Rozana Sten at 3075 2472 or Annette Midtgaard Hvilsom at +45 3079 3461. Deadline 15 November 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Undervisning og forskning på universiteter og højere læreranstalter

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

GÆLDER

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