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 its 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
• 5+ years of experience in analytical development
• Experience with analytical techniques for small drug molecules and oral solid formulations, 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 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

South San Francisco, CA. Fully onsite; remote applicants will not be considered.

Pay

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

Benefits

• Generous stock option grants for all employees
• 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