Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

Role: Process Development Senior Scientist specializing in early-stage biologics drug product development, primarily monoclonal antibodies and multispecifics. Responsibilities: design and optimize liquid/lyophilized formulations; establish scalable fill/finish processes; evaluate CQAs such as aggregation and stability; implement advanced data science tools like AI/ML; author regulatory documentation; support tech transfer and manufacturing troubleshooting; collaborate cross-functionally across research, process development, regulatory, and manufacturing teams. Requirements: PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field; 2–4 years postdoctoral or industry experience in biologics formulation and stability; proficiency in analytical/biophysical techniques (UPLC/HPLC, SEC, etc.); experience with clinical-stage biologics development, regulatory submissions, and process scale-up. Preferred: expertise in biologics stability, drug substance and drug product development, and automation/AI implementation. HighValue: biologics modalities (monoclonal antibodies, multispecifics); early to clinical manufacturing phases; process development, formulation, and regulatory support; cross-functional collaboration in a biotech setting. WorkSetup: not specified; likely hybrid or onsite depending on location.