Remote Senior Bioanalytical Lead – ADC Programs

george james ltd; France; À distance; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Unknown company in France is seeking a Senior Bioanalytical Manager to oversee the development and qualification of bioanalytical methods for ADC programs. You will coordinate transfer and validation of assays at CROs supporting clinical studies, ensuring GLP compliance and regulatory readiness, while guiding method transfer between laboratories.

The role requires deep experience in regulated bioanalysis of large molecules, exposure to ELISA/LC-MS/MS assays and strong collaboration with clinical

Qualifications

• The candidate has extensive experience in regulated bioanalysis of large molecules.
• Experience with method transfer and validation in CROs is essential.
• Strong familiarity with ICH M10 and GLP requirements.

Responsabilités

• Oversee development and qualification of bioanalytical methods for ADC programs.
• Coordinate transfer and validation of assays at CROs for clinical studies.
• Ensure GLP compliance and regulatory expectations for analyses.
• Lead method transfer between laboratories and support IND/CTA submissions.
• Provide scientific leadership across preclinical and clinical programs.

Connaissances

Bioanalytical methods

ELISA/ligand-binding

LC-MS/MS

Regulatory GLP/ICH M10

CRO management

IND/CTA submissions

English fluent

French advantageous

Formation

PhD in Analytical Biochemistry

Outils

LIMS

ELN

Office software

Description du poste

Unknown company in France is seeking a Senior Bioanalytical Manager to oversee the development and qualification of bioanalytical methods for ADC programs. You will coordinate transfer and validation of assays at CROs supporting clinical studies, ensuring GLP compliance and regulatory readiness, while guiding method transfer between laboratories.

The role requires deep experience in regulated bioanalysis of large molecules, exposure to ELISA/LC-MS/MS assays and strong collaboration with clinical