Principal Scientist, Formulation & Drug Product Development

Role: Principal Scientist leading formulation and drug product process development for Denali’s protein biologics portfolio. Responsibilities: independently drive formulation activities, understand degradation mechanisms, design formulation studies, support process scale-up and validation, perform biophysical characterization using chromatography and spectroscopy, translate critical quality attributes into stable formulations, author technical regulatory documents, oversee CMO manufacturing and troubleshooting, and collaborate cross-functionally with discovery, analytical, bioprocess, and quality teams. Requirements: PhD in Chemical Engineering, Pharmaceutical Sciences, Biophysics, or Analytical Chemistry with 10+ years industry experience in protein therapeutics formulation; hands-on expertise in analytical protein characterization, biophysical methods, high concentration formulations, and process validation; strong statistical and analytical skills; proven success in CMO tech transfer and regulatory support. Preferred: experience with prefilled syringes, combination devices, GMP compliance, and cross-functional collaboration. High-Value: biologics (protein therapeutics), formulation development, CMC, GMP, regulatory filings, at early clinical or later stages. WorkSetup: not specified; salary range $159K-$207K.