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Copenhagen

    Senior CMC Project Manager - Copenhagen, Danmark - Genmab

    Genmab
    Genmab Copenhagen, Danmark

    for 5 dage siden

    Genmab background
    Fuldtid
    Beskrivelse

    The Role

    Genmab is now searching for a (Senior) Project Manager CMC to join the New Product Introduction (NPI) CMC Team in Copenhagen.

    The (NPI) CMC Team is part of CMC Operations in Copenhagen, which now has close to employees. CMC Operations is responsible for development and manufacture of Genmab antibody drugs used in preclinical, clinical, and commercial settings. The New Product Introduction Team is responsible for CMC development from late discovery through preclinical and clinical proof of concept. The NPI team also proceeds with further CMC development and manufacture until the Late-Stage Manufacturing Development Team takes over a project for late-stage CMC activities.

    As responsible CMC Lead, the (Senior) CMC PM will be generating and executing the overall CMC strategy and planning within selected projects from the Genmab NPI portfolio. The (Senior) CMC PM will be part of a team of CMC PMs supported by specialists for e.g. assay/process development, product characterization and Fill Finish. The CMC New Product Introduction Team at Genmab currently employs close to 30 people and you will report to Associate Director, Team Lead, New Product Introduction.

    Responsibilities

    The responsibilities will include, but not be limited to:

    • Overall responsible for strategy and execution of CMC development towards CTA/IND and clinical proof of concept
    • Managing CMC activities at CMOs and supervision of internal process and assay development work
    • Internal alignment in the CMC Management Team governing a CMC program within Genmab
    • CMC representative in the Compound Development Team, governing the development program within Genmab
    • Reviewing regulatory CMC submissions provided by the CMC Writer Team
    • Supporting and follow up on CMO and internal quality events as e.g. changes or deviations
    • Supporting the maintenance of CMC Operations' quality system
    • Budget oversight and responsible, project planning and internal governance

    Requirements

    • You have a proven track record and the technical skills of biological process development and biopharmaceutical manufacturing
    • At least 4 years of experience within CMC project management
    • GMP knowledge and insight into regulatory requirements as well as understanding of CMC principles and industry practices for biopharmaceuticals.
    • At least 4-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale
    • For a Senior CMC PM position, approx. 8 years of working experience, preferably including both early and late-stage CMC programs of antibodies or large biologic molecules, would be expected.
    • As Genmab is moving into new antibody formats and modalities, experience as CMC PM from either antibody drug conjugate projects and/or chemical engineering small molecule API synthesis would also qualify into a Senior CMC PM position.
    • Fluency in English.
    • Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture of investigational drugs, therefore experience in running projects with external CMO partners is preferred.

    Moreover, you meet the following personal requirements:

    • Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals.
    • An independent work-approach and good at building solid professional relations to collaborators and business partners.
    • You have a quality mindset
    • You are organized with a sense of details
    • You are result- and goal-oriented and committed to contributing to the overall success of Genmab
    • You find it comfortable to work in an agile biotech environment
    • You are curious and like to challenge existing processes
    • You are proactive and open minded

    Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

    About You

    • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
    • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
    • You are a generous collaborator who can work in teams with diverse backgrounds
    • You are determined to do and be your best and take pride in enabling the best work of others on the team
    • You are not afraid to grapple with the unknown and be innovative
    • You have experience working in a fast-growing, dynamic company (or a strong desire to)
    • You work hard and are not afraid to have a little fun while you do so

    Locations

    Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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