Bioanalytical Manager
Coopers
Basel-Stadt, Switzerland
vor 3 Tg.

Responsibilities

  • Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs
  • Responsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.
  • Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant / interaction compound in the given project.
  • Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.
  • Participate actively in PS subteams, act as primary contact person for DMPK project leader.
  • Act as Bioanalytical Leader when required. Interact proactively with the assay development team.
  • Ensure full compliance with the current global and local bioanalytical guidance and GxPs.
  • Leadership in Bioanalysis : *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required;
  • maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.
  • Provide technical leadership in issue resolution.
  • Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.
  • Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.
  • Maintain open links with other disciplines within the department and the organization.
  • Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues
  • Must haves :

  • Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis
  • Excellent work experience on both large and small molecules bioanalysis
  • Strong vendor management experience, looking after outsourced studies to external CROs
  • Degree in biology / biochemistry
  • Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Klicke auf "Weiter", um unseren Datenschutz-und Nutzungsbestimmungen zuzustimmen . Du kriegst außerdem die besten Jobs als E-Mail-Alert. Los geht's!
    Weiter
    Bewerbungsformular