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Process Development Senior Scientist

Amgen
September 01, 2026
Full-time
Remote friendly (Cambridge, MA)
Worldwide
Operations
Role: Process Development Senior Scientist focusing on biologics drug substance processes, supporting late-stage (Ph II/III) clinical programs to facilitate commercial manufacturing. Responsibilities: develop, characterize, scale-up, and troubleshoot biologics processes across modalities such as antibodies, oncolytic viruses, bispecifics, and siRNAs; collaborate cross-functionally with analytical, drug product, and manufacturing teams; author technical reports and contribute to CMC regulatory submissions; ensure processes are cGMP-compliant. Requirements: Doctorate in Chemical/Biochemical Engineering or related sciences, or Master’s with 2+ years, or Bachelor’s with 4+ years in life sciences; strong expertise in protein chromatography, filtration, and protein characteristics; experience in process troubleshooting and developing robust, scalable processes; knowledge of regulatory and cGMP environments. Preferred: track record of scientific publications, leadership experience, familiarity with design of experiments, and regulatory filings. High-Value: biologics, multiple modalities, late-stage clinical development, cGMP manufacturing, CMC documentation, cross-functional collaboration. Work Setup: not specified.