Bioanalytical Manager a Basel

pubblicato
contatti
Barbara Sorce, Basilea Professionals Health Care & Life Sciences
tipologia
Altri contratti
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specifiche della posizione

pubblicato
luogo di lavoro
Basel, Basilea-Città
settore
Life Sciences
tipologia
Altri contratti
riferimento
15739
contatti
Barbara Sorce, Basilea Professionals Health Care & Life Sciences
telefono
058 201 55 50

descrizione

For our client, a pharmaceutical company in the Basel area we are looking for an

Bioanalytical Manager 

  • Start date: middle May 2021, latest August 2021
  • End date:18 months
  • Extension: possible
  • Work location: Basel
  • Remote/Home Office: home office at the moment

Background:

This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.

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
  • Excellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or small
  • Strong vendor management experience, looking after outsourced studies to external CROs (*****)
  • Degree in biology/biochemistry (*****)