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 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 We are 34 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. The formulation development covers from early phase development of oral protein formulations and processes in small scale to later stages of formulation development with 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 Drug Product Coordinator 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 our primary project planning system. Plan the timing of department activities together with department team leaders and other project coordinators. Communicate risk based development and pilot manufacture scenarios to the project core 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. Scientific experience with Solid Dosage Form drug development and manufacture is a great advantage for the candidate as is knowledge in protein analysis, characterization 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 hectic 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 use our skills, dedication and ambition to help peop

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark