A fantastic long term contract has arisen for a Bioanalytical Manager in Switzerland, you will be responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development.
- Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs
- Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound.
- 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.
- Remain current and continually develop expertise in bioanalytical science.
- Guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.
- 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 organisation.
- Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues
Skills and Requirements
- Degree in biology/biochemistry
- Minimum 3 years in a similar position focused on bioanalysis in pharmaceuticals or CRO
- Excellent work experience on both large and small molecules bioanalysis
- Strong vendor management experience, looking after outsourced studies to external CROs
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.