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Principal Engineer - Synthetic Process Development
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$200
Full-time
- In this vital role is accountable to drive lab-based technical solutions and provide overall guidance and leadership for the development, characterization, and technology transfer of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization and lifecycle management.
- To achieve this goal, the Principal Engineer will partner multi-functionally with Amgens chemistry, analytical, drug product, quality, safety, and operations teams to ensure successful transfer, implementation, and validation of Amgens drug substance processes at internal and external clinical and commercial manufacturing facilities.
- Process Development: supporting the development of chemical processes and positioning drug substance processes for commercialization success by designing and performing experimental plans; leading, implementing and deploying process-analytical tools (PAT) to enable process understanding and design; process simulation using an array of process modeling and engineering tools; and process characterization.
- Experience building and applying first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.
- Proficiency in lab-based implementation of and data interpretation for wide variety of analytical methods, process analytical tools, and solid-state characterization methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
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