Scientist, CMC Analytical Development
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Job Description
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.
We are seeking a highly motivated Scientist of Analytical Development to join our dynamic small molecule CMC analytical group. The successful candidate will use their knowledge, experience, and skills to conduct analytical development activities for drug candidates from the preclinical phase through late-stage clinical development.
Responsibilities- Conduct in-house analytical laboratory activities independently with minimal guidance 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
Location: Please note that this is a lab-based position, so the expectation is to be onsite in South San Francisco 4-5 days a week.
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.
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants.
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.
