Job Properties
  • Job Type
    Full-time Position Internship / Part Time
  • Category
    Research & Science
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Nijmegen
    • Date Posted
      November 12,2021
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK

    Bioprocess Technologist / Principal Scientist DSP

    0.8-1.0 FTE

    Application deadline: November 19, 2021

    Xenikos B.V. is looking for a Bioprocess Technologist / Principal Scientist to strengthen its team as the company moves through phase 3 clinical testing of its flagship product T-Guard®. The new employee will report to the COO and will join us in the preparations to file for Marketing Authorization in the US and EU within the coming years, and beyond that into commercialization and the expansion of our product portfolio.

    Responsibilities
    As Bioprocess Technologist at Xenikos, you will manage biopharmaceutical manufacturing process optimization and -implementation, process characterization and -validation. The company operates in a semi-virtual mode, not running own laboratories or plants, so your work will also include the (selection, qualification and) oversight of third-party service providers (CDMOs). You will author and review technical and regulatory submission documents, protocols and reports, and you will be involved in OOS, Non-conformance and root cause investigations. Adequate control of process- and manufacturing changes is a key element of the job. Besides Change Control we expect the new employee to contribute in a broader sense to the further development of the Quality System as required to allow Xenikos to become a commercial manufacturer.

    Further development and refinement of the control strategies surrounding the processes to manufacture the immunotoxins and the intermediates that are conjugated to form them will be part of your scope.

    You are able to maintain records according to Good Documentation Practices while adhering to the company’s policies and procedures, conduct risk- and trend analyses, and contribute to the selection of analytical methods needed to support manufacturing. You will be expected to manage your own work schedule effectively and efficiently and to keep up to date with the latest scientific and technical developments.

    Work environment
    Founded in 2009, Xenikos is a small Biotech company of 9 employees operating from Nijmegen, the Netherlands, developing innovative new immunotherapies based on conjugated antibodies. Our flagship product T-Guard® resets the immune system in patients who have a severe immune disease or developed post-transplantation rejection. This therapeutic approach is now entering Phase 3 testing for the second-line treatment of steroid-resistant acute graft-versus-host disease (SR-aGVHD) a life-threatening condition common in patients following hematopoietic stem cell transplantation.

    At Xenikos you will join the CMC group, currently 5 employees strong. We strive to build an inclusive and safe working environment, with open lines of communication and we embrace diversity. You will be working in a close-knit team of professionals (MSc/PhD level) in an inspiring and dynamic working environment where you will be helping to save patient’s lives and your input is valued. If you dream of a job where you are at the forefront of today’s science and where your contribution can really make a difference, then Xenikos is for you.

    What we expect from you

    Education & Experience:
    • A University degree (or an equivalent level of proficiency gained through experience) in bio(process)technology, biochemistry, or a related discipline;
    • Experience in DSP mid-to late-stage process development, process characterization, process validation and -commercialization;
    • Proven affinity with, and broad understanding of biopharmaceutical manufacturing;
    • Understanding of GMP requirements and, in particular, process validation aspects;
    • A minimum of 5 years relevant working experience, preferably within the biopharmaceutical industry;
    • Thorough understanding of relevant CMC development aspects and pertinent regulatory processes.
    Profile:
    • A pioneering mindset;
    • Ability to deal with complexity and conflicting interests and priorities;
    • Builder of relationships within an international collaboration network;
    • Ability to change perspective between the bigger picture and the technical details;
    • Language skills: English and (preferably) Dutch, level C1/C2;
    • Team player who can think on their feet, is capable of working independently and is assertive, well-organized and helpful.
    What we have to offer
    • An employment contract for 0,8 - 1,0 FTE;
    • Office in Nijmegen, flexibility in working remotely;
    • A competitive salary, based on experience, plus an 8% holiday allowance;
    • 25 vacation days (based on 1.0 FTE);
    • Duration of the contract is negotiable;
    • An inclusive, inspiring and innovative working environment, with room for personal growth;
    • The opportunity to help bring a potentially life-saving treatment to patients that currently have no alternative treatment option.
    Additional information
    The starting date of the employment contract is open to discussion, but preferably as soon as possible.
    We are an equal opportunity employer, and as such encourage applications from minorities, and from any gender or race.

    Questions?
    For more information about this vacancy, please contact:
    Maarten Frijlink, Chief Operating Officer
    Telephone: +31 6 19 45 37 57
    E-mail: info@xenikos.com

    Interested?
    Please send your application to l.huberts@xenikos.com. Make sure to include a letter of motivation, as well as your resumé.
    Incomplete applications will not be considered.

    Application Deadline
    Please send in your application by November 19th, 2021.
     
    Open Positions from Xenikos
    • There are no eligible results.

    Related positions