For our client, a leading pharmaceutical company with headquarters in Basel, we are looking for a motivated and experienced:
Bioanalytical Manager Small Molecules
As part of the Roche Pharma Research and Early Development organisation in Basel, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is 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.
The ideal candidate is someone who had a similar position in bioanalysis previously within a regulated environment: pharma (preferred) or a CRO or an experienced scientist with experience with small molecule bioanalysis very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). The successful candidate will have an education within chemistry/ biology / biochemistry. This is a contract with potential internal opportunity afterwards.
Please note onsite work will be required when possible. The specifics (days onsite vs home office) will be discussed later with the manager. Please note remote work is not an option and we expect candidates to be able to be onsite. Therefore, please do NOT send any candidates not willing to relocate or not already here.
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
- Interact proactively with the assay development team
- Ensure full compliance with the current global and local bioanalytical guidance and GxP
- Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical sciences. 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 the 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
- 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 small molecule bioanalysis in a regulated environment
- Strong vendor management experience, looking after outsourced studies to external CROs
- Degree in chemistry/ biology/ biochemistry
Start date: ASAP
Latest start date: 3 months' notice is acceptable
End date: 18 months contract
Work location: Basel
Remote/Home Office: Onsite work will be required when possible
Team: 22 people
Please apply online. For further information about the position, please contact your Kelly recruiter, Judith Atgé Martin (+41 61 270 80 16)