For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
As Bioanalytical Manager, you will be responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Regulated Bioanalysis acts as an interface for the conduct of bioanalytical development projects in cooperation with external contract research organizations (CROs), various internal pre-clinical and clinical stakeholders and health authorities. 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.
- 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.
- Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO 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
Place of work: Basel
Duration: 18 month, extension possible
Please apply online. For further information about the position, please contact: Mrs Diana Steinhauer (+41 61 270 80 16).