stillingsbetegnelse: Senior Drug Product Coordinator

jobbeskrivelse:
- Research Scientist - Denmark - Måløv An exciting job for an experienced project leader is available in Injectable Project Office – a department dedicated to developing the next generation of biopharmaceuticals, from early phase to late phase clinical trials and registration. About the department Injectable Project Office is part of Injectable Protein Formulation in the R&D area Chemistry, Manufacturing and Control (CMC) Development. The department is located in Måløv (Copenhagen, Denmark) and consists of 21 highly skilled technical coordinators. We are responsible for coordinating the development of formulations, production processes and analytical methods for freeze dried and soluble injectables of new therapeutic proteins. We are involved in development and research projects within haemostasis, diabetes, obesity and growth hormones. The position We are looking for an experienced project leader – a drug product coordinator - to coordinate projects within our broad portfolio. 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. Qualifications The person we are looking for ideally has 3-5 years of experience in managing CMC activities covering early phase to late phase clinical development. Scientific experience with drug development and manufacture is a great advantage for the candidate as is knowledge in protein analysis and formulation. A M.Sc 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. Working at Novo Nordisk 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 Per Jeppesen at + 45 3075 0049. Deadline 5 June 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