stillingsbetegnelse: Drug product coordinator - Solid Dosage Forms

jobbeskrivelse:
- Research & Development - Denmark - Måløv Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Are you looking for new challenges within formulation, process or analytical method development of solid dosage forms and project management. Our Oral Protein Formulation Unit (OPF) in Måløv is expanding, and 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 covering early to late phase clinical trials including pilot production, scale-up and analysis of solid protein dosage forms. About the department We are 36 scientists and technicians in Oral Formulation & Process Development organized in two teams. The department is overall responsible for development of Solid Dosage Forms of Insulin and GLP-1 molecules for oral delivery. Formulation development covers from early phase development of oral protein formulations and processes in small scale to later stages of formulation development in 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 We are looking for an experienced project manager (Drug Product Coordinator) with drug development experience to coordinate oral product portfolio projects. As a Drug Product Coordinator you will be responsible for aligning the project organisation needs with those of the Line of Business. You will be part of the CMC core project team along with the other technical coordinators, e.g. API and analysis, as well as collaborate closely with the departmental oral product development groups. In this dual role you will define specific department activities linked to the overall project key deliverables. 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 a project planning system. Plan the timing of department activities together with department team leaders and other project coordinators on an oral portfolio level. Communicate risk based development and pilot manufacture scenarios to the CMC core project group. Clear and timely communication of project requirements to team and department members. Prepare and coordinate regulatory documentation according to international guidelines. Drive continuous improvements using LEAN/Six Sigma approach. Qualifications The person we are looking for ideally has 3-5 years of experience in managing CMC activities covering early 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. Previous project management experience and/or scientific experience with Solid Dosage Form drug development and manufacture 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. You are able to stay focused in a complex and challenging 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 use our skil

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