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Bioanalytical Manager
5 months ago
As part of my clients Pharma Research and Early Development organisation, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinicaldevelopment. The group of Regulated Bioanalysis and Biosample Operations acts as an interface for the conduct of bioanalytical development projects in cooperation with external contract research organizations (CROs), various internal pre-clinical and clinicalstakeholders and health authorities. This position will be focused on external CRO management.
- The hiring team is not apposed to applicants who are experienced scientist with strong focus on large molecules very keen to learn and with a positive attitude, however, preference would be someone who has experience in a similar position.
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. 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
