Senior Scientist, Analytical Development — Small Molecules

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

Benefits offered by this job

Stock options

Annual bonus

Health insurance 90% employee

Genentech bus & ferry

Cell phone stipend

Unlimited PTO

Onsite gym

Job summary

Alumis Inc. in South San Francisco, CA, is hiring a Sr. Scientist I of Analytical Development to bolster our small molecule CMC group.

You will support method development, validation, and transfer at CMOs/CTLs from preclinical through late-stage clinical development. The ideal candidate holds a BS/MS in chemistry or pharmaceutical sciences and 5+ years in analytical development, with hands-on experience in UPLC/HPLC, LC-MS, KF, and dissolution testing, plus CMOs/CTLs and regulatory knowledge

Qualifications

• BS/MS in chemistry or pharmaceutical sciences with at least 5 years in analytical development.
• Experience with analytical techniques for small drug molecules and oral solid formulations (UPLC/HPLC, LC-MS, KF, dissolution).
• Experience with CMOs/CTLs and regulatory requirements (ICH, cGMP).
• Strong communication and cross-functional collaboration.
• Ability to thrive in a fast-paced small company environment.

Responsibilities

• Support development, validation, and transfer of analytical methods for starting material, intermediates, drug substance and drug product at CMOs/CTLs.
• Execute and/or support in-house method development using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation from Phase 1 to late-stage development.
• Review CMO/CTL analytical data, protocols and reports.
• Trend stability and release data using statistical methods.
• Assist in investigations of non-conformance events at CMOs/CTLs.
• Collaborate with CMC team, QA and CMOs/CTLs to generate and approve documents.
• Communicate scientific results within cross-functional teams, orally and in writing.
• Author technical reports and regulatory submission documents (IND, IMPD, NDA).
• Assist in preparation of CMC documents for regulatory submissions.

Skills

Analytical development

Cross-functional teamwork

Regulatory awareness

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. in South San Francisco, CA, is hiring a Sr. Scientist I of Analytical Development to bolster our small molecule CMC group.

You will support method development, validation, and transfer at CMOs/CTLs from preclinical through late-stage clinical development. The ideal candidate holds a BS/MS in chemistry or pharmaceutical sciences and 5+ years in analytical development, with hands-on experience in UPLC/HPLC, LC-MS, KF, and dissolution testing, plus CMOs/CTLs and regulatory knowledge