Scientist, CMC Analytical Development Specialist
17 hours ago
Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. We are seeking a highly motivated Scientist of Analytical Development to join our dynamic small molecule CMC analytical group.
Key Responsibilities- Conduct in-house analytical laboratory activities independently, 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).
- 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.
- 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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