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Senior Scientist I Analytical Development

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. The small molecule CMC team is seeking highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to support the analytical development and quality control activities from the preclinical phase through late-stage clinical development. Having analytical development expertise and experience in working with CMOs/CTLs, coupled with thorough understanding of the associated quality and regulatory awareness are key assets.RESPONSIBILITIESSupport development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLsExecute and/or support the in-house method development activities using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation and techniques for Phase 1 to late-stage drug developmentReview CMO/CTL analytical data (in-process, release, and stability data), protocols and reportsTrend stability and release data using statistical methodsAssist in investigation for various non-conformance events at CMOs/CTLsCollaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documentsCommunicate scientific results (oral and written) in a clear and concise manner within cross-functional teamsAuthor technical reports and documents in support of regulatory filingAssist in preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)THE IDEAL CANDIDATEBS/MS in chemistry or pharmaceutical sciences with 5+ years of experience in analytical developmentExperience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniquesProven track record in applying analytical techniques to solve challenging problemsExperience in working with CMOs and CTLsExperience in early to late-stage drug developmentStrong organizational and communication skillsComfortable in a fast-paced small company environment and a strong team playerExperience and knowledge in ICH, cGMP and regulatory requirementsThis 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 $112,000 USD to $135,000 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.Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.Other benefits include:Health insurance premiums paid at 90% for employee, 80% for dependentsFree access to Genentech Bus & Ferry Share program$100 monthly cell phone stipendUnlimited PTO for Exempt employeesFree onsite gym and a kitchen stocked with yummy snacks and drinks!