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Senior Scientist II, CMC Analytical Development
2 months ago
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 seeks a highly motivated Sr. Scientist II of Analytical Development to join our dynamic small molecule CMC analytical group. The successful candidate will use their knowledge, experience, and skills to manage and conduct analytical development and quality control activities to advance Alumis drug candidates through the clinical phases to commercial products.
Responsibilties
- Manage and guide both in-house and outsourced CMC development activities independently with minimal guidance, such as analytical method development, method transfers and validations, sample and reference material management, and release and stability testing.
- Conduct hands-on in-house analytical laboratory activities for Alumis programs as needed including development of new methods, troubleshooting methods, and analytical testing to support clinical phase projects.
- Characterize 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 critically review analytical documents independently, such as method development and validation protocols/reports, batch release reports and CoAs, stability protocols/reports, and other technical documents.
- Independently execute in accordance to ICH, EMA, and/or pharmacopeia expectations.
- Actively assist in the preparation of CMC documents for INDs, IMPD’s, and NDAs.
The Ideal Candidate
- PhD/MS in chemistry or pharmaceutical sciences is desirable.
- 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.
- Previous experience supporting both immediate release and modified-release drug product formulations is preferred.
- Ability to design, execute, interpret data & present to the team.
- Ability to mentor junior researchers and organize and coordinate external resources.
- Ability to represent the function on project teams contribute to the group and communicate the outcomes to the broader team.
- Expected to make inventive contribution.
- Ability to influence and provide strategic contributions at team level.
Alumis Values
• Elevate
• Challenge
• Nurture
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 $170,000 USD to $180,000 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.
