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A leading pharmaceutical company is seeking an experienced scientist to join their Bioanalytical and Molecular Assays team. This role supports regulated clinical studies and trials, integrating regulated bioanalysis and basic science research to advance programs and identify pipeline opportunities.
Job Responsibility
Design and execute phase-appropriate bioanalytical strategies, including quantitation of therapeutic proteins, immunogenicity and PK/PD assay method development, validation, and sample testing under GcLP
Develop assays using technologies such as ELISA, MSD, multiplex LBAs, and immunoblotting
Ensure timely qualification or validation of assays is fit for purpose, meets regulatory standards, and troubleshoot issues internally or with external CRO partners
Support internal bioanalytical capability, manage analytical equipment qualifications, prepare and maintain SOPs, and control critical reagents
Collaborate with operations and sample management to define the sample journey
Requirements
Expert knowledge of GLP and GCP requirements, current industry trends, and regulatory expectations associated with bioanalytical science
Knowledge of Watson LIMS
Ability to handle multiple projects in a fast-paced environment and effectively communicate scientific concepts, program objectives, and data analysis
Experience with RNA, biologics, and cell therapy
Knowledge of various ligand binding assay platforms such as ECL and cell-based assays
Previous work experience in a CRO or bioanalytical lab within a regulated environment
Experience with Lab Information Management Systems (LIMS) and electronic lab books (eLNB)