Bioanalytical Manager Large Molecules (w/m/d) 100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

Bioanalytical Manager Large Molecules (w/m/d) 100%

Tasks & 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 (first option preferred)
  • Excellent work experience of large molecules bioanalysis in regulated PK, ADA and Biomarkers
  • Strong vendor management experience, looking after outsourced studies to external CROs
  • Degree in biology/biochemistry
  • Ability to apply the regulations from validation to sample analysis and troubleshoot virtually

General information:

  • Start date: asap
  • Duration: 18 months, extension possible
  • Workplace: Basel
  • Workload: 100%
  • Home Office: hybrid

 

Marilu Mercedes
Marilu Mercedes
Telefon: 058 255 31 04

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