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

THE IDEAL CANDIDATE

• 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
• Bilingual in Japanese/English and able to act as a technical translator for written and verbal communication and technical documents strongly preferred

EDUCATION

• PhD. Organic Chemistry, Chemical Engineering, or related field

The salary range for this position is $140,000 USD to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.