For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Bioanalytical Manager Small Molecules
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 internal pre-clinical and clinical stakeholders, external contract research organizations (CROs) and health authorities.
The successful candidate will interact with external CROs and internal project teams for conducting small molecules bioanalytical work according to regulatory guidance. He/she will manage full bioanalytical support for the assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs.
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 development compounds (drugs) and any concomitant/interaction compound in the given project.
- Manage and direct analysis of samples and timelines from preclinical and clinical studies for the project at CRO labs.
- Participate actively in expert teams; act as primary contact person for DMPK and clinical project leaders.
- Ensure full compliance with the current global and local bioanalytical guidance and GxP.
- 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.
- Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO or scientist focused on bioanalysis
- Excellent work experience on small molecules bioanalysis
- Strong vendor management experience, looking after outsourced studies to external CROs
- Degree in chemistry/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).