Senior Scientist I, Analytical Dev – Small Molecules

BioSpace; South San Francisco (CA); On-site; USD 112,000 - 135,000; Full time

Benefits offered by this job

Health insurance premiums paid

Genentech Bus & Ferry Share program

$100 monthly cell phone stipend

Unlimited PTO

Free onsite gym and snacks

Job summary

Alumis Inc. is seeking a Sr. Scientist I of Analytical Development to help build our small molecule CMC group in South San Francisco, CA. The role supports analytical development and quality control from preclinical to late-stage clinical development.

The ideal candidate will have BS/MS in chemistry or pharmaceutical sciences with 5+ years of analytical development experience, plus hands-on expertise with UPLC/HPLC, LC-MS, KF, and dissolution methods, and CMOs/CTLs collaboration.

Qualifications

• 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 including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization.
• Proven track record in applying analytical techniques to solve challenging problems.
• Experience in working with CMOs and CTLs; early to late-stage drug development; familiarity with ICH, cGMP and regulatory requirements.

Responsibilities

• Support development, validation, and transfer of analytical methods to CMOs/CTLs.
• Execute and/or support the in-house method development activities using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation 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 (IND, IMPD, NDA).

Skills

Analytical development

Small molecule analytics

CMC collaboration

Communication

Education

BS/MS in chemistry or pharmaceutical sciences

Tools

UPLC/HPLC

LC-MS

KF

Dissolution testing

IR

Particle size analysis

Solid-state characterization

Job description

Alumis Inc. is seeking a Sr. Scientist I of Analytical Development to help build our small molecule CMC group in South San Francisco, CA. The role supports analytical development and quality control from preclinical to late-stage clinical development.

The ideal candidate will have BS/MS in chemistry or pharmaceutical sciences with 5+ years of analytical development experience, plus hands-on expertise with UPLC/HPLC, LC-MS, KF, and dissolution methods, and CMOs/CTLs collaboration.