Bioanalytical Manager
Bioanalytical Managers lead teams responsible for the development and validation of analytical methods that measure drug levels and biomarkers in biological matrices. Their work supports pharmacokinetic, toxicokinetic, and immunogenicity studies.
Key duties:
Overseeing LC-MS/MS and ligand-binding assays – For plasma, serum, urine, or tissue analysis.
Managing GLP and GCLP-compliant operations – Ensuring data integrity and readiness for regulatory submission.
Leading method validation and transfer – Collaborating with CROs or internal labs to standardise assays.
Supervising scientists and analysts – Ensuring resource allocation and mentorship across studies.
Interacting with clinical and regulatory teams – Supporting INDs, NDAs, and study reports with validated data.
This role requires deep analytical expertise, regulatory understanding, and project leadership in bioanalytical sciences.