Senior Bioanalytical Manager
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Location: Remote (France, The Netherlands, UK or Ireland)
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Reference: JVM191026A
Our Client is very well funded French based biotech company focused on the development of antibody drug conjugates for high unmet need diseases such as cancer. Their lead program is in Phase I.
The Senior Bioanalytical Manager is accountable for the bioanalytical methods supporting the ADC programs, from their development and qualification for preclinical studies to their transfer and validation at the bioanalytical CRO selected by the clinical department. The role holder will make sure that every method needed for the clinical studies (total antibody, conjugated antibody, free payload and immunogenicity assays) is robust, fit for purpose, fully validated and compliant with regulatory expectations before the first clinical sample is analysed.
Within the preclinical team, the role holder will manage the bioanalytical CROs supporting all nonclinical studies. For clinical programs, the role holder will act as the scientific and technical lead for method transfer and validation, working hand in hand with the clinical department, which selects and manages clinical vendors and owns clinical sample analysis and data interpretation. As in any lean organisation, this role will be expected to influence outcomes through expertise and collaboration rather than hierarchical authority
The role demands an experienced expert in regulated bioanalysis of large molecules with hands-on expertise gained in a Biotech, Pharma or CRO environment. Exposure to the development, validation and transfer of ligand-binding (ELISA, MSD or equivalent) and LC-MS/MS methods, in line with ICH M10 is needed along with solid experience with immunogenicity assays (ADA, NAb) and their validation.
Demonstrated experience of managing bioanalytical CROs, including method transfer between laboratories is essential as is working knowledge of GLP requirements and regulatory inspections. xwjxdcb Experience with ADC bioanalysis and multi-analyte strategies would be an advantage along with experience in critical reagent generation and lifecycle management and contributing to the bioanalytical sections of IND or CTA submissions.
The ability to work in English is essential and French would be a great advantage
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