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 technique s 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)
THE IDEAL CANDIDATE
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 k nowledge in ICH, cGMP and regulatory requirements
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 $112,000 USD to $135,000 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.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
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 yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate , challenge and nurture one another along the way.
Benefits
Health insurancePaid time offRemote work optionsEquity / stock optionsPerformance bonus
Additional Information
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 Dev e lopment 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.
Alumis · South San Francisco