Senior Scientist, Chemical Development

Alumis•South San Francisco, CA

8d•$140,000 - $160,000•Onsite

About The Position

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).

Requirements

Knowledge of cGMP, ICH, and regulatory requirements
Bilingual in Japanese/English and able to act as a technical translator for written and verbal communication and technical documents
PhD. with minimum of 5 years of experience in small molecule drug substance development, including management of external vendors/CDMOs or MS with minimum of 8 years of experience is desirable
Experience with late-stage drug substance technical transfer
Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes
Highly proficient oral and written communication abilities
Strong presentation skills highly desired
Excellent collaboration, problem-solving, and organizational skills
Comfortable in a fast-paced small company environment
Ability to travel domestically and internationally (including Asian countries) up to 25% of the time to support ongoing manufacturing activities

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%).