Principal Scientist, Analytical Development & Formulation

Role: Lead analytical and formulation development for biologics in immuno-oncology and autoimmune diseases, supporting preclinical to clinical stages. Responsibilities: develop and validate analytical methods, design formulation studies, oversee stability and reference material programs, collaborate with cross-functional teams (Research, Quality, Regulatory), and provide technical leadership. Qualifications: Ph.D., M.S., or B.S. in chemistry, biology, or engineering with 4-10+ years industry experience, extensive expertise in biologics analytical and formulation development, regulatory compliance (FDA, ICH, cGMP), and managing external CROs/CMOs. HighValue: biologics (proteins), immuno-oncology, autoimmune indications, preclinical/clinical phases, regulatory documentation, GxP environment, advanced analytical techniques, QbD principles. WorkSetup: On-site in San Diego, CA, with a full-time schedule.