Scientist, CMC Analytical Development

Alumis 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 a highly motivated Scientist of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to support analytical development activities for drug candidates from the preclinical phase through late-stage clinical development. Having extensive hands-on analytical development expertise and prior experience in working with CMOs/CTLs, coupled with understanding of the associated quality and regulatory awareness are key assets.

RESPONSIBILITIES

• Perform analytical method development for drug substances, starting materials, intermediates and drug products for small molecules
• Provide analytical support for in-house CMC development and non-GLP toxicology studies
• Characterize physical and chemical properties of drug candidates
• Identify and characterize drug impurities and degradation products
• Assist in method transfer and validation to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
• Review in-process, release and stability testing data for drug substances and drug products at CMOs/CTLs
• Summarize batch analysis data and track impurities throughout the drug substance synthetic process
• Monitor stability studies and trend stability and release data using statistical methods
• Review analytical documents and development reports
• 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 preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)

THE IDEAL CANDIDATE

• BS/MS with 8+ years of experience in chemistry or pharmaceutical sciences in analytical development
• 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 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
• We Elevate
• We Challenge
• We Nurture

This position is located in South San Francisco, CA. No remote candidates will be considered.

The salary range for this position is $120,000 USD to $150,000 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. 

If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster.