Associate Director, Formulation Development

Role: Formulation Scientist within the CMC Development team, focusing on biologics drug product formulation for early- and late-stage development. Responsibilities include designing, optimizing, and characterizing biologics formulations, especially high-concentration systems for subcutaneous delivery, conducting stability and degradation studies, and supporting regulatory documentation (IND/IMPD/BLA). The role provides technical leadership, mentorship, and supports technology transfer activities. Qualifications: PhD with 2+ years or MS with 6+ years in biologics formulation development; expertise in analytical techniques (chromatography, spectroscopy, light scattering, calorimetry); strong understanding of protein stability, degradation mechanisms, and structure-property relationships. Preferred: background in Pharmaceutics, Chemistry, Chemical Engineering, or Biochemistry; experience mentoring; familiarity with regulatory filings. HighValue: biologics modalities, high-concentration formulations, early- and late-stage development, analytical characterization, regulatory support, biologics (mammalian/bacterial-derived), stability and developability assessments. Work setup: hybrid role based in Bridgewater, NJ, with occasional travel (~5–15%).