stillingsbetegnelse: Senior CMC Project Manager

jobbeskrivelse:
- Project Management - Denmark - Bagsværd We are looking for a new Senior CMC Project Manager in CMC Development/R&D to play a key role in developing new and world-class biologic pharmaceutical products. About the department CMC Project Planning and Management (PPM) is a central CVP unit in CMC Development with the responsibility of planning and managing the CMC part of the entire Novo Nordisk portfolio of development projects. We lead the projects from research to first launch, while ensuring optimal cross-functional collaboration across CMC Development and with other functional areas within R&D and Product Supply. We are 30 skilled and dedicated employees organised into portfolios of projects. Our ambition is to drive CMC activities in drug development projects efficiently, timely and in an innovative way by focusing on customers and setting new standards across the organisation. Our new colleague will be assigned to the CMC Diabetes Injectables portfolio. The job You will be responsible for CMC projects during the development phases ensuring efficient transfers from Global Research to CMC Development and later to Product Supply. Overall this means that you will be responsible for managing the development of the product and manufacturing processes, for securing timely supply to non-clinical and clinical studies and for providing the corresponding documentation to Health Authorities. You will prepare and execute the CMC development strategy and plan incl. project scenario building and risk management and in this connection you will interact with internal stakeholders as well as external parties (e.g. CMO, Health Authorities). In order to do this you will manage the cross functional CMC Core Teams involving all relevant CMC disciplines and you will represent the CMC area in relevant project teams outside CMC Development. You will be reporting to the VP of the portfolio. Qualifications You hold a relevant Master or PhD degree within a relevant field of scientific expertise (preferably within synthetic peptides). You have solid working experience within the different parts of the CMC field and you possess solid knowledge within the CMC value chain, drug development, pharmaceutical industry and regulatory requirements. You have several years of experience in successful project management and preferably also within line management. You have excellent people, collaboration and communication skills and have strong ability to create winning teams. You create overview and clear direction and use a structured approach while solving complex tasks. You display a high level of personal engagement, drive, independence and integrity. You find it rewarding to work towards reaching your own project’s goals while also engaging in activities across projects. You are fluent in both written and spoken English at a professional level. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Britt Gren Sjøholm at +45 3075 2002 or Pia Thorbek at +45 3079 2109. Deadline 8 February 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