Senior Regulatory Affairs Officer

Vollzeit | Marburg, HESSEN | etwa ein Monat




  • For our Plasma Product Development R&D department we are looking for a

    Scientist (f/m)

    (full-time / limited until 11/2019)

    Job Purpose

    The Scientist will be responsible for performing R&D studies and analytical testing to support technical activities for plasma derived proteins and recombinant products. The Scientist will support the successful performance of PPD by providing scientific and analytical support for development studies, validation studies and for global clinical and preclinical studies. The Scientist will also support Commercial Development/ Operations for competitor product profiling and other analytical investigations. The position is within a regulated certified laboratory.

    Main Responsibilities and Accountabilities

    • Supporting the performance of bioanalytical and pharmaceutical studies.
      • Creating and performing experimental protocols and study related documents. Release of study results.
      • Provide scientific and analytical support to deviations.
      • Provide analytical support for improvement of plasma derived proteins and recombinant products.
      • Support analytical activities in routine business within predefined timelines.
    • Planning, performing, evaluating and developing analytical methods.
      • Creating, performing and supervising experimental protocols and designs.
      • Developing innovative methods and optimizing procedures.
    • Writing and revising technical documents including lab SOPs, test and validation protocols and reports
    • Compiling and presenting results
    • Maintains awareness of cGXPs guidelines and systems needed in a laboratory.
    • Provides effective and transparent communications to laboratory team, colleagues, Quality, CRD, and other departments.
      • Regularly participate in technical, operational and organizational discussions and presentations at team and department meetings.

    Qualifications / experience

    • Academic scientific qualification, e.g. Master of Science in Biochemistry or related area with 5 years of industrial experience;
      or Doctorate in Biochemistry or related area with 0-2 years of relevant industry experience.
    • Strong scientific background in coagulation, immunology, intensive care medicine and/ or protein sciences with        broad (bio-) analytical spectrum of methods.
    • Proven ability to work efficiently, both independently or in a team setting, and meet set goals by managing own timelines.
    • Experience in working in cross-functional, multicultural and international teams.
    • Experience in project work. Excellent communication and analytical skills.
    • Strong planning and organizational skills. Fluent in English, oral and written.
    • Proficient computing and software skills (MS office suite, DOE, instrument software, statistical and graphical analysis, LIMS systems, business management systems).

    If you are interested in this challenging position, please apply via our website.

    Marburg, 10.09.2018 

    CSL Behring GmbH

    Human Resources

    Position number: R-075978

    Worker Type:


    Worker Sub Type:


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