stillingsbetegnelse: Senior Drug Product Coordinator (Project Leader)

jobbeskrivelse:
. Research Scientist . Denmark - Måløv A challenging job for an experienced project leader is available in Biopharm Formulation Development – a department dedicated to developing the next generation of biopharmaceuticals, from early phase to late phase clinical trials and registration. About the department Biopharm Formulation Development is part of Injectable Protein Formulation in the R&D area CMC Supply. The department is located in Gentofte (Copenhagen, Denmark) and is divided into 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 freeze dried and soluble injectables of new therapeutic proteins and monoclonal antibodies. We are involved in development and research projects mainly within haemostasis and inflammation. Due to our rapidly increasing project portfolio, we are now facing new exiting challenges. The job We are looking for an experienced project leader – a drug product coordinator - to coordinate projects within the biopharm portfolio. You will be part of the departmental team of 6 drug product coordinators, and will work in close collaboration with scientists and technicians. 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 ideally 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. Scientific experience with drug development and manufacture is a great advantage for the candidate as is knowledge in protein analysis and formulation. 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 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. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please contact Malin Gustavsson at + 45 3079 4524. Deadline 18 August 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: +45 44448888

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark