Director, Process Development

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Job description

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.

We are seeking an experienced highly motivated Director of Process Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will be responsible for developing the manufacturing process of the drug substance and transferring the technology to our contract development and manufacturing organizations (CDMOs). The candidate will be able to direct and oversee contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).

Responsibilities

• Lead CDMO activities in drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization for early phase to late-phase drug development
• Lead the design and execution of chemical development strategies and provide direction to the CROs and CDMOs during clinical development, registration batches, process validation, review, and evaluate release testing data
• Serve as subject matter expert in drug substances and help drive best practices and technical advancements
• Provide technical guidance and oversight (both internally and externally) to drive the phase-appropriate drug substance development
• Apply principles of quality by design (QbD) to identify critical quality attributes (CQA) and to establish phase appropriate control strategies
• 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 technological 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 12 years of industry experience with PhD is desired in small molecule drug substance development, including management of external vendors/CDMOs
• Strong leadership with excellent collaboration and organizational skills
• Expert knowledge in the design and execution of chemical development strategies
• Capable of utilizing QbD principles to develop commercially viable manufacturing processes
• Strong knowledge of cGMP, ICH, and regulatory requirements
• Strong and independent problem-solving, ability to troubleshoot relevant to process chemistry issues is a must. Hands-on experience in working in the lab to solve process chemistry issue is highly desired.
• Highly proficient oral and written communication abilities
• Comfortable in a fast-paced small company environment
• Ability to travel domestically and internationally to Alumis external CROs and CDMOs

Education

• PhD./MS in Organic Chemistry

Alumis Values

• Elevate

• Challenge

• Nurture

This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.

The salary range for this position is $220,000 USD to $235,000 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.

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