Research Scientist

• Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function.
• Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work.
• Provide oversight into external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review and edit SOPs, protocols, reports, and quality related documentation.

Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control

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