Job Properties
  • Job Type
    Full-time Position
  • Category
    Administration & Operations
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Nijmegen
    • Date Posted
      August 19,2022
    • IMG_6430
    • VISA
    • Premium Package

    Head of Manufacturing - Biologics Based Medicines

    Application deadline:
    15/09/2022
    Expected Start Date:
    ASAP
    Contacts:
    Penny de Villiers
    Mobile: +31 639103707
    Company homepage:
    www.byondis.com
    Office address:
    Microweg 22, 6545CM Nijmegen


    Byondis B.V. is an independent, Dutch biopharmaceutical company creating precision medicines targeting intractable cancers and autoimmune diseases. We are passionate about transforming patients’ lives. We are pioneering and bold in action.

    The Head of Manufacturing plays a critical role in building site capabilities on our journey to become a center of excellence for individualized therapy manufacturing. The plant is located on the Byondis Campus in Nijmegen, Netherlands. We are seeking an experienced and enthusiastic manufacturing lead who will provide direct technical and managerial leadership to the manufacturing team.

    The plant currently produces cell banks, monoclonal antibodies and antibody-drug conjugates Drug Substances in our state of the art cleanroom facilities. Activities comply with cGMP and safety regulations and contain service activities like media and buffer preparation, mammalian cell culture and downstream processing as well as conjugation of high potent drugs to the antibodies.

    Your Role

    You will be responsible to further expand manufacturing capabilities to support the growing pipeline, resulting in multiple new manufacturing processes into the GMP facilities to support current clinical studies and preparation for commercial manufacturing. This role will provide you with the creativity and challenge to bring your commercial experience and pioneer the implementation of commercial manufacturing systems.

    You will advise and influence senior management on manufacturing best practices (policy, governance, strategic planning, operating model and processes etc.) This role is responsible for defining and developing manufacturing planning to support our strategic vision.

    Your role is that of critical business partner to the COO to ensure product is delivered on time to meet the needs of the clinical supply and commercial demand plans. You will work closely with other departments within the operation such as Technical Operations, Quality Control, Quality Assurance and CMC Project Management as well as with Development, Maintenance and Engineering, Supply Chain and Regulatory Affairs and be part of the Development Management Team.

    Summary of Job Functions
    • Ensure facilities are maintained in a constant state of inspection readiness and GMP compliant including staff and all related elements such as equipment, documentation (SOPs and batch manufacturing records etc.), training and reports.
    • Accountable for Quality systems records completion by set compliance expectations
    • Effectively retain, develop, and lead a diverse team of 27 professional and foster the important value at Byondis of creating an inclusive work environment.
    • Create an environment of “can do” teamwork, open communication, and a sense of urgency.
    • Foster a culture of safety and compliance, driving with “right first time” approach, that embraces safety in the work environment and the safety of the patients
    • Assist in the setup of manufacturing areas and equipment/fixtures and performance of facility and equipment commissioning and qualificationWriting technically sound manufacturing operating procedures, promote effective and efficient operations, and comply with cGMP requirements
    Your Profile
    • Bachelor’s degree required, in chemical engineer, biochemical engineering or biological sciences.
    • Experience as a leader of Manufacturing Operations in a Biotechnology or Pharmaceutical manufacturing organization
    • Comprehensive understanding of cGMP requirements for clinical and commercial pharmaceutical manufacturing
    • Experience in Biologics based medicines would be ideal
    • Experience in the implementation of batch records
    • Proven leadership skills resulting in a well-organized, motivated and productive team
    What we Offer

    Besides a competitive salary, we offer you a dynamic working environment at our state of the art campus in Nijmegen. Our values as integrity, authenticity, entrepreneurship, quality and trust are very highly regarded. We also offer an excellent pension scheme, 30 days annual holidays based on a fulltime position and we organize several company events throughout the year. Relocation allowance is made available to non-Dutch citizens.

    Application

    Explore this opportunity and apply today CV's will be reviewed and feedback given within 10 days of your application.


    Acquisition by commercial agencies is
    not required.

     
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