Development Scientist II, Analytical Development and Quality Control

Job description

Are you ready to turn deep protein characterization into decisions that shape the quality, safety and success of biologics reaching patients? Do you thrive on translating complex charge and size variant data into clear strategies that stand up to regulatory scrutiny and accelerate development? In this role, you will lead analytical characterization from clinical through commercial stages, strengthening the scientific backbone of our biologics programs. You will design and optimize high-impact methods, drive comparability and forced degradation studies, and author CMC sections that guide regulatory filings. Working with cross-functional teams, you will convert data into direction—pinpointing critical quality attributes, de-risking process changes, and enabling faster, better decisions for our pipeline. Accountabilities: - Protein Variant Enrichment and Characterization: Lead enrichment, fractionation and characterization of protein size and charge variants to define and monitor critical quality attributes, guiding process and formulation strategies. - Analytical Method Development and Optimization: Conduct studies and develop/optimize robust HPLC/UPLC, CE-SDS, icIEF and related meth...