Principal Scientist, Method Development & Validation

Job description

A brief overview The Principal Scientist, Method Development & Validation will fulfill a critical role in QC GMP operations. This individual helps to guide development of release/stability and in-process analytical methods for all peptide drug substances/finish products and raw materials at Bachem America sites. The individual will work closely together mainly with process development, production manufacturing, QC material testing, QC IPC, and QC API testing to understand and align analytical strategies. This individual will support method development, validation, and method transfer, including authoring technical quality documents (method, protocols, reports, etc.), execution of protocols and review of data and technical documents. In addition, this individual performs special projects such as peptide characterization, impurity identification, and other special studies as necessary. This individual conducts or contributes to investigations and the identification and implementation of corrective actions. This individual contributes to advances in analytical capabilities and innovations for the Quality Control department. This individual proactively provides solutions to resolve ana...