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Zwijnaarde

    Supervisor Pharma - Zwijnaarde, België - Start People Gent (Orban)

    Start People Gent (Orban)
    Start People Gent (Orban) Zwijnaarde, België

    1 week geleden

    Default job background
    Vast contract
    Beschrijving
    Description

    The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule

    You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.

    RESPONSIBILITIES

    The CAR-T Operations Supervisor will lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.

    The CAR-T Operations Supervisor will need to build strong partnerships with Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain / Warehouse to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for technicians and experts on the production floor.

    Company

    Our client, Legend Biotech, based in Zwijnaarde, is a global biotechnology company bringing the innovative CAR-T cell therapy to Ghent. With this, the Legend Biotech team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases.
    They are currently in a phase of strong growth and are looking for motivated and dedicated team members.

    Profile

    Education

    • Bachelor's or Master's degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.

    Experience

    • A minimum of 5 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
    • At least 3 years of aseptic GMP manufacturing experience (grade A/B or C).

    Capabilities, Knowledge, and skills:

    • Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
    • Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
    • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
    • Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
    • Strong analytical, problem solving, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
    • Can do attitude, Right first time and Hands-on approach
    • Self-motivated, enthusiastic personality, team player
    • Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
    • Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
    • An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
    • Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
    Offer
    • You will join an exciting pharmaceutical company with opportunities for growth.
    • You will work within a strong and respectful diverse team where everyone is welcome.
    • You will receive an attractive salary package including meal vouchers and eco vouchers.
    • Hospitalisation insurance, group insurance and bonus complete the salary package.
    • You will work in a 2-shift system (6 am - 4 pm / 2 pm - 00 am) in a regime in which you work 4 days, have 4 days off, etc. This gives you a nice balance between Work and Personal life
    • You will work in an environment where loyalty and team spirit
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