Senior Manager, Analytical Sciences
Core
Provide scientific and technical leadership for analytical activities supporting biologic products from clinical development through post-approval support.
Role type
Senior Manager, Analytical Sciences
Builds
Biologic drug substances and drug products
Domain
Biopharmaceuticals / Oncology
Required skills
Analytical method development, validation, and transfer, Extended product characterization, Comparability assessments, Regulatory submission authoring, ICH guidelines knowledge, External partner management, Scientific writing, Data interpretation, Project management
Preferred skills
Advanced degree in analytical chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or biology
Technologies
HPLC, LC-MS, CE, NMR, Mass Spectrometry, Chromatography
Responsibilities
Lead analytical method development, qualification, validation, and transfer activities; Design and oversee extended product characterization studies; Develop analytical strategies and execute comparability assessments; Author and review analytical sections of regulatory submissions; Manage contract laboratories and external partners; Partner cross-functionally with Process Development, Formulation, Manufacturing, Quality, and Regulatory Affairs.
Seniority
Senior Manager, hands-on IC with team leadership