Senior Scientist I Analytical Development

Alumis•South San Francisco, CA

8d•Onsite

About The Position

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.

Requirements

BS/MS in chemistry or pharmaceutical sciences with 5+ years of experience in analytical development
Experience 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 techniques
Proven track record in applying analytical techniques to solve challenging problems
Experience in working with CMOs and CTLs
Experience in early to late-stage drug development
Strong organizational and communication skills
Comfortable in a fast-paced small company environment and a strong team player
Experience and knowledge in ICH, cGMP and regulatory requirements

Responsibilities

Support development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
Execute 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 development
Review CMO/CTL analytical data (in-process, release, and stability data), protocols and reports
Trend stability and release data using statistical methods
Assist in investigation for various non-conformance events at CMOs/CTLs
Collaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documents
Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
Author technical reports and documents in support of regulatory filing
Assist in preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)