Senior Manager Bioanalytics (m/f)
Fresenius SE & Co. KGaA
vor 14 Tg.

Senior Manager Bioanalytics (m / f)

  • Manage projects and represent R&D Bioanalytics on development teams
  • Attend team meetings, develop timelines for product delivery, and ensure compliance with appropriate regulations interfacing with R&D, Clinical Development, Regulatory Affairs, and CROs
  • Advise CROs on scientific, SOP, and regulatory issues
  • Develop and maintain partnerships with CROs
  • Ensure consistency in practices and documentation in context of global regulations
  • Review and evaluate CRO validation and analytical reports, participate in technical audits
  • Generate nonclinical and clinical reports and develop draft responses to regulatory questions
  • Support scientific, regulatory, and department perspectives in decision making
  • Scientific degree in Chemistry, Biochemistry, or similar field
  • Several years' relevant work experience in the pharmaceutical or biotech industry
  • Demonstrated record of bioanalytical accomplishment, preferably with biosimilars
  • Experience in developing modern bioanalytical methods for quantification of drugs and anti-drug antibodies and in transferring and validating established methods
  • Knowledge of GLP and Bioanalytical Guidance documents
  • Experience in providing scientific oversight for bioanalytical projects
  • Excellent communication, organizational, and interpersonal skills
  • Fluency in English; French and German would be assets
  • Note : Please send your application online or by mail to the Human Resources Department in Aubonne / Switzerland, Fresenius Kabi SwissBioSim GmbH , Aylin Wölki.

    For a significant screening of your application documents we require your current CV.

  • Career level :
  • Professional Experienced
  • Working condition :
  • Permanent contract / Full-time
  • Location :
  • International / Aubonne
  • Closing date for applications :
  • None. We look forward to your application.
  • Bewerben
    Meine Email
    Wenn Sie auf 'Fortsetzen' klicken, akzeptieren Sie unsere Datenschutz- und Nutzungsbedingungen und stimmen zu, relevante Email-Alerts zu erhalten (Sie können sich jederzeit abmelden). Hier ansehen