SeniorScientist,ChemicalDevelopment

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Alumis team is seeking a highly motivated Senior Scientist, Chemical Development to join the Technical Operations / Chemistry, Manufacturing, and Controls (CMC) team at Alumis. The successful candidate will support process development efforts as well as oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). ESSENTIAL DUTIES & RESPONSIBILITIES Drive CDMO activities for late-stage drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization. Provide technical guidance and oversight (both internally and externally) to drive the phase appropriate drug substance development. Serve as subject matter expert in chemical development and help drive best practices and technical advancements. Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports. Draft the CMC sections of regulatory filings, including IND/IMPDs and NDA/MAAs Document development activities as source reports for regulatory filings. Work effectively with the cross-functional CMC team to ensure timely delivery of drug substance throughout the full drug lifecycle. Implement best practices and drive continuous improvements in the drug substance development process through technology innovation and problem solving. Proactively identify risks and communicate effectively with functional teams across all levels of the organization. Work in the lab to solve process chemistry issues (20% - 40%) Knowledge of cGMP, ICH, and regulatory requirements Bilingual in Japanese/English and able