As a preferred supplier for Roche Diagnostics in Basel, Switzerland, we are looking for a dedicated personality as Bioanalytical Manager (contract for 18 months, with extension if it is a fit for all parties) start date within 3 months.
Remote / Home Office is possible.
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 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.
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
ERFORDERLICHES PROFIL :
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 IF not both, either large or small
Strong vendor management experience, looking after outsourced studies to external CROs
Degree in biology / biochemistry
Interested? You can find more information here : Infopackage . Apply online via the "Bewerben" link below. Please answer all questions, otherwise we cannot process your application.