Alumis 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 small molecule CMC team is seeking a highly motivated Associate Director of Chemical Development Operations who will be responsible for leading the late-stage manufacturing activities critical to the successful development for the lead program at Alumis. The successful candidate will be able to direct and oversee contract development and manufacturing organizations (CDMOs) as well as lead process development efforts in preparation for successful late-stage manufacturing.
- Lead CDMO activities for late-stage drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization
- Apply principles of quality by design (QbD) to identify critical quality attributes (CQA) and to execute design of experiment (DOE) studies intended to identify proven acceptable ranges (PARs) and establish critical process parameters (CPPs)
- Provide technical guidance and oversight (both internally and externally) to drive the phase appropriate drug substance development
- Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports
- Author 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 to functional teams across all levels of the organization
THE IDEAL CANDIDATE
- PhD./MS in Organic Chemistry, Chemical Engineering, or related field
- Minimum of 10 years of industry experience in small molecule drug substance development, including management of external vendors/CDMOs
- Capable of utilizing QbD principles to develop commercially viable manufacturing processes
- Experience in late phase drug substance process validation, pre-approval inspection, and commercial manufacturing
- Strong knowledge in cGMP, ICH, and regulatory requirements
- Highly proficient oral and written communication abilities
- Excellent collaboration, problem-solving, and organizational skills
- Comfortable in a fast-paced small company environment
- Ability to travel domestically and internationally up to 25% of the time to support ongoing manufacturing activities
- We Elevate
- We Challenge
- We Nurture
This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.
The salary range for this position is $174,775 USD to $208,949 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.