Description
Job DescriptionAt the Senior Scientist level, the incumbent will be senior member of the Analytical Development team, providing technical leadership as well as conducting independent experiments in the development, optimization and validation of bioassays. The senior scientist will also oversee life cycle management activities for bioassays and will contribute to development and implementation of other analytical techniques used for characterization and quality control products of drug substance and drug product.
MAJOR DUTIES OF POSITION : Develop, optimize and validate in vivo and in vitro test methods (e.g. ELISA) as a potency test method for release and stability monitoring of development and commercial drug products. This includes development of reagents (e.g. monoclonal antibodies), reference standard and controls.Oversee life cycle management activities for potency assaysCollaborate with others within the development and research department, actively support development of test methods and testing of new drug candidates at various stages of development. Create and review technical and regulatory documents including analytical method development reports, method validation protocols and reports, standard operating procedures in compliance with regulatory requirements. Manage the activities of external laboratories that have been contracted to conduct assay development or sample testing.Manage technical transfer of assays to QC and contract laboratories in a cGMP environment.