Process Development Scientist

Role: Process Development Scientist supporting Amgen's drug product commercialization and lifecycle management, focusing on synthetic process development for biopharmaceutical products. Responsibilities: design and execute characterization studies, evaluate manufacturing process impacts, author process transfer and regulatory documents, support technology transfers, and contribute to process validation and lifecycle management across clinical and commercial facilities. Collaborate with cross-functional teams including engineering, analytical, quality, regulatory, and manufacturing. Requirements: Master’s degree in Chemical/Biochemical Engineering, Biochemistry, or related field; minimum 2 years of experience in process development or related roles. Skills: statistical data analysis, process scale-up, process validation, process transfer, technical documentation, and laboratory skills such as aseptic handling and bench-scale operations. High-value: expertise in biopharma process development, process validation, regulatory document authoring (e.g., module 3), and experience with oral solid dosage or synthetic characterization. Work environment may include remote work. The position involves technical support for commercial product lifecycle and process improvements.