CMC Project Director for Strategy Execution

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Søborg

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 [xxxxx] 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 [xxxxx]’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 [xxxxx], but also to relevant external partners such e.g. CMOs. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For questions, please contact Lau Brüniche-Olsen, PoVP (CMC Cardiovascular, Kidney & AD) at +45/ [xxxxx]or Henrik N. Ferré, PoVP (CMC Rare Diseases and Advanced Therapies) at +45/ [xxxxx]. Deadline 17 April 2024. Please note that we will conduct interviews on an ongoing basis, so please submit your application as soon as possible. You do not need to attach a cover letter to your application, but we encourage you to include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 3.4.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 03.04.2024
    • Projektleder
    • Søborg

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