- Provide analytical support for both in-house and outsourced CMC development activities, such as analytical method development, method transfers and validations, sample and reference material management, and release and stability testing.
- Support the characterization of drug impurities and degradation products as well as other physical and chemical properties.
- Review CMO/CTL analytical data (in-process, release, and stability data) and drive the data correction and approval process to completion.
- Monitor release and stability data, track and trend the data using appropriate statistical methods, and compile the data into reports and presentations.
- Collaborate with cross-functional teams (CMC teams, QA, Regulatory, and CMOs/CTLs) to drive Alumis projects forward to meet project timelines.
- Write and/or review analytical documents, such as method development and validation reports, batch release reports and CoAs, stability reports, and other technical documents in support of regulatory filings.
The Ideal Candidate - BS or MS in chemistry or pharmaceutical sciences with minimum 3-5 years of experience in an analytical method development environment.
- Experience with small molecule analytical techniques used for testing of clinical phase drug substances and drug products, such as UPLC/HPLC, LC-MS, GC, KF, UV/Vis, IR, particle size analysis, dissolution testing, DSC, TGA, and XRPD.
- Experience with review of GMP batch release and stability study data generated at CMOs and CTLs.
- Self-motivated to complete assigned tasks in a timely manner in order to advance the project pipeline.
- Strong organizational, communication, and collaborative skills.
- Solid knowledge in ICH, cGMP and regulatory requirements for small molecule drug substances and drug products.
Alumis Values
• Elevate
• Challenge
• Nurture
This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.
Alumis Inc. is an equal opportunity employer -
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Scientist, CMC Analytical Development - South San Francisco, United States - Alumis Inc.
Description
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 Alumis team is seeking a highly motivated Contract Scientist of Analytical Development to join our dynamic small molecule CMC analytical group. The successful candidate will use their knowledge, experience, and skills to support analytical development activities to advance Alumis drug candidates through the clinical phases to commercial products.
Responsibilities
