Senior Scientist I Analytical Development

About the role

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. The small molecule CMC team is seeking a highly motivated Sr. Scientist I of Analytical Development to help build our dynamic small molecule CMC group. The successful candidate will support analytical development and quality control activities from the preclinical phase through late-stage clinical development.

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 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)

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

Location

This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.

Pay

The salary range for this position is $112,000 USD to $135,000 USD annually. This range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Benefits

• Generous stock option grants for all employees as well as an annual bonus program
• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with snacks and drinks