CMC Project Director for Strategy Execution - Søborg, Danmark - Novo Nordisk A/S - VTx

    Novo Nordisk A/S - VTx
    Novo Nordisk A/S - VTx Søborg, Danmark

    for 2 uger siden

    Novo Nordisk A/S - VTx background
    Fuldtid
    Beskrivelse

    Are you looking for an exciting opportunity within CMC project management and strategy execution in close collaboration with key stakeholders? Are you motivated by leading complex projects within growing therapy areas? Do you want to deliver visible footprints and utilize your excellent project leadership skills by setting the direction and motivate your cross functional project teams?

    If yes, then we have the right position for you in CMC Development & Scaling (CMC) as CMC Project Director, where you will join a dedicated team of Project Directors all responsible for their own project portfolio. Come join us, apply today

    The Position

    You can look forward to a broad range of exciting challenges that have senior management attention feeding into your personal and professional development. With direct reference to a Portfolio Vice President (PoVP), you will manage CMC projects during the development phases ensuring efficient transfers from Global Research Technologies to CMC and later to Product Supply for commercial production.

    Your main responsibilities will be:

  • Project management - managing the development of product and manufacturing processes, securing timely supply to non-clinical and clinical studies as well as providing the corresponding documentation to Health Authorities.
  • Stakeholder management – developing strong internal and external networks. Interact with internal stakeholders as well as external parties (e.g. Contract Manufacturing Organisations (CMOs) and Health Authorities).
  • Project team – managing, supporting and motivating the cross functional CMC development core teams involving all relevant CMC disciplines. You will represent the CMC area in the Global Project Team.
  • Strategy execution - preparing and executing on the CMC development strategy and plan incl. project scenario building and risk management. Our working environment is flexible, dynamic and informal with a strong culture of cross-functional collaboration, where your contributions will be valuable and make a difference. We are committed to digitalisation and automation and see these as key enablers to reach our strategic aspirations. Qualifications You hold a Master or PhD degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar. You possess solid knowledge of the CMC value chain, as well as drug development and regulatory requirements. You have several years (+5 years) of experience in successful project management from R&D or manufacturing development. As a person you:
  • have excellent collaboration and communication skills. You are a talent in engaging and motivating teams with diverse backgrounds and communication in a clear way.
  • set a clear direction, solve complex tasks and create overview in relation to business strategies and project scope with a curious and structural approach.
  • display a high level of independence, personal engagement, drive to reach results as well as integrity.
  • find it rewarding to work towards reaching your own project's goals while also engaging in activities across projects.
  • have full proficiency in both written and spoken English. About the CVP area and department As part of Novo Nordisk PSQIT organization, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. CMC is the link between research and production supplying products needed for all of Novo Nordisk's clinical trials around the world. We develop, manufacture, and distribute drug candidates for clinical trials and develop commercial manufacturing processes and technologies with consistent scientific documentation for drug approval. In CMC Portfolio Management, we are responsible for all CMC development projects. All the way from lead drug candidate selection, throughout phase 1, 2 and 3 clinical development, project transfer to commercial manufacturing, regulatory submission and approval. The area is the link between CMC and stakeholders across Novo Nordisk, but also to relevant external partners such e.g. CMOs.