Senior Manager, Biologics Analytical Research and Development

Senior Manager, Biologics Analytical Research and Development position available at a clinical-stage biotech company. Responsible for developing strategies to solve complex analytical problems, collaborating with external contract manufacturing and testing organizations, and ensuring timely and successful development of pipeline drug candidates.

Requirements

• BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience, advanced degree highly preferred
• Demonstrated experience in analysis of biologics, including Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE-SDS, CEIEF) techniques, PCR, and cell-based potency assays and ELISA based assays
• Prior experience with analytical method development for fusion proteins/ bi-specific antibodies is a plus
• Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment in support of biologics drug development programs
• Strong working knowledge of analytical methodologies, Critical Quality Attributes/QbD/DOE principles, and data analysis and statistics for setting specifications
• Ability to design and direct the development/qualification of release, characterization, and stability assays to support clinical drug substance / drug product testing and product/process development
• Working knowledge of LIMS, Veeva, SAS and/or JMP is a plus
• Working knowledge of quality systems, GMP, FDA, ICH, and EMEA guidelines for stability, especially in biologics
• Strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

Benefits

• Competitive salary
• Opportunity to work with a small, clinical-stage biotech company
• Remote work option