Process Development Senior Associate

Role: Process Development Senior Associate focused on late-stage drug product formulation and fill/finish process development for large molecule biologics (e.g., monoclonal antibodies, bispecific T-cell engagers, fusion proteins). Responsibilities: design and execute formulation and process studies, analyze product performance via analytical techniques, automate data analyses using digital tools, author technical protocols and reports, and collaborate with engineering and scientific teams for drug product commercialization and lifecycle management. Qualifications: Master’s degree or equivalent experience (minimum 2 years for Bachelor’s or 4 years for Associate’s degree, 6 years for high school diploma), with preferred background in chemical or biomedical engineering, biochemistry, or related fields. Experience in pharmaceuticals/biotech process characterization, formulation development, equipment design, technology transfer, and familiarity with unit operations such as ultrafiltration, filtration, mixing, and relevant analytical methods (SEC, CEX, etc.) are desired. Skills in statistical software (SAS, JMP), programming (Python, R), and data visualization (Spotfire, Tableau) are advantageous. High-value specifics include biologics modalities, late-stage development, and process optimization. The role involves cross-functional collaboration within Amgen’s R&D and manufacturing teams. Work setup and travel details are not explicitly stated.