Bioanalytical Manager

Hobson Prior are currently looking for a Bioanalytical Manager to join an amazing pharmaceutical organisation on a contract basis with the ability to work from home 1 day a week. Our client is focused on creating new medications and diagnostic tests.

Please note that to be considered for this role you must have the right to work in this location.

Key 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.

Requirements:

• Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred).
• A Degree in chemistry/ biology/ biochemistry.
• Excellent work experience on small molecule bioanalysis in a regulated environment.
• Strong vendor management experience, looking after outsourced studies to external CROs.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.