Scientist, CMC Analytical 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 a highly motivated Scientist of Analytical Development to join our dynamic small molecule CMC analytical group. The successful candidate will use their knowledge, experience, and skills to conduct analytical development activities for drug candidates from the preclinical phase through late-stage clinical development.

Responsibilties

• Conduct in-house analytical laboratory activities independently with minimal guidance including method development and testing for drug substances, starting materials, intermediates and drug products for small molecules
• Characterize drug impurities and degradation products as well as other physical and chemical properties
• Manage laboratory equipment and in-house material inventory
• Assist in method transfer and validation at CMOs/CTLs
• Review CMO/CTL analytical data (in-process, release, and stability data) and reports
• Monitor release and stability data, track and trend the data using statistical methods
• Collaborate with CMC team, QA, and CMOs/CTLs towards timely generation and approval of documents
• Assist in investigation for various non-conformance events at CMOs/CTLs
• Write technical reports and documents in support of regulatory filing
• Assist in the preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)

The Ideal Candidate

• BS/MS with 5+ years of experience in chemistry or pharmaceutical sciences is desirable
• Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LCMS, GC, KF, UV/Vis, IR, particle size analysis, dissolution testing, DSC, TGA, and XRPD
• Experience in oral tablet dissolution method development preferred
• Proven track record in applying analytical techniques to solve challenging problems
• Experience in working with CMOs and CTLs is a plus
• Self-directed and motivated
• Collaborative and good team player
• Strong organizational skills and communication skills
• Experience and knowledge in ICH, cGMP and regulatory requirements

Alumis Values

• Elevate
• Challenge
• 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 $136,000 - $160,000 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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