Associate Director, Formulation Development

About The Role We’re looking for a Formulation Scientist on the CMC Development team. You’ll lead drug product formulation development activities for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. You will also provide technical leadership and mentorship to junior scientists. What You’ll Do Design, develop, and optimize biologics drug product formulations (aqueous and non-aqueous) Develop high-concentration formulations for subcutaneous delivery Characterize and optimize excipient systems, buffers, and stabilization strategies; evaluate stability, aggregation, viscosity, and degradation pathways Conduct forced degradation and stress studies to define formulation design space Lead analytical characterization of biologic molecules and formulations (e.g., higher-order structure, aggregation, particle formation, colloidal behavior) Investigate degradation pathways, structure-function relationships, and critical quality attributes; develop/qualify/implement analytical methods for formulation screening and optimization Provide technical leadership for formulation strategy, candidate selection, and developability assessments Support late-stage activities (comparability, stability strategy, lifecycle management) Author/review/approve technical reports, protocols, and regulatory documentation (IND/IMPD/BLA) Lead/support technology transfer to internal manufacturing sites and CDMOs (formulation/characterization) Who You Are PhD with 2 years’ experience in formulation development, or MS with 6 years’ experience. You Are Or You Also Have Biologics drug product formulation experience (aqueous and/or non-aqueous) Advanced analytical techniques (chromatography, spectroscopy, light scattering, calorimetry) Strong biologics analytical characterization skills (SEC, DLS, DSC, spectroscopy) Knowledge of protein stability, degradation mechanisms, and structure-property relationships Experience supporting early- and late-stage development programs Nice To Have (Not Required) Degree in a related field Mentoring/leading experience Fast-paced, matrixed environment experience CDMO/external partner hands-on experience Regulatory filing familiarity (IND, IMPD, BLA) Technical/scientific leadership and strategic lifecycle thinking Where You’ll Work Hybrid role based in Bridgewater, NJ (remote most of the time; in-person collaboration as needed) Occasional travel: ~5%–15% #J-18808-Ljbffr Scorpion Therapeutics