Lead Scientist, Small Molecule Analytics & QC

Immunomeinc; Bothell (WA); On-site; USD 170,000 - 196,000; Full time

Job summary

Immunome, Inc. seeks an experienced Principal Scientist, Analytical Development and QC, Small Molecule, to advance our small molecule programs from discovery through regulatory submissions.

The role combines method development, validation, transfer, and oversight of CDMOs, with emphasis on robust analytical strategies for complex molecules. You will work cross-functionally with discovery, chemistry, quality, and regulatory teams, author CMC sections, and help build internal capabilities for

Qualifications

• Ph.D. with 3 years or MS with 8 years or BS with 10 years in biopharmaceutical industry.
• Experience developing, validating, troubleshooting, and transferring analytical methods for small molecules.
• Experience overseeing CDMOs, CROs, and contract testing labs.

Responsibilities

• Develop and execute phase-appropriate analytical methods for LP intermediates and related testing.
• Lead method development, qualification, validation, transfer, troubleshooting, and lifecycle management.
• Oversee external labs to ensure timelines, quality, and regulatory compliance.
• Investigate method performance, deviations, and OOS/OOT with root-cause analysis.
• Contribute to regulatory submissions and technical reports with data interpretation.
• Create SOPs, protocols, and reports to support GMP activities and submissions.

Skills

LC/GC/LC-MS/MS

NMR

Impurity profiling

Degradation studies

Analytical method development

Regulatory submissions support

Education

Ph.D. in Analytical Chemistry

M.S. in Chemistry

Tools

CDMO oversight

Job description

Immunome, Inc. seeks an experienced Principal Scientist, Analytical Development and QC, Small Molecule, to advance our small molecule programs from discovery through regulatory submissions.

The role combines method development, validation, transfer, and oversight of CDMOs, with emphasis on robust analytical strategies for complex molecules. You will work cross-functionally with discovery, chemistry, quality, and regulatory teams, author CMC sections, and help build internal capabilities for