Bioanalysis - Hertfordshire, United Kingdom - Reed Scientific
Description
Bioanalytical Manager
18 Month FTC
Hybrid working
Daily:
£400 - £450 Ltd/UMB pay rate or £ £335.65 PAYE basic pay
Hertfordshire area, UK
REED Scientific are representing a global pharmaceutical company whose achievements help to transform the lives of millions of people. Their UK site is a key part of their global research and development programme.
About the Job
- Lead bioanalytical strategies to generate decisionenabling bioanalytical data with skilled data interpretation to meet and answer project needs
- Responsible for outsourcing activities in Bioanalytics (bioanalysis of nonclinical 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), antidrug 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 managethe 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
The company is offering a competitive salary as well as a supportive and inclusive culture, with a strong focus on employee development.
If this looks of interest and you meet the requirements, don't miss this opportunity
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