Lead Scientist, Small Molecule Analytics & QC

Immunome, Inc.; Bothell (WA); On-site; USD 170,000 - 196,000; Full time

Job summary

Immunome, Inc. in Bothell, WA seeks a Principal Scientist for Analytical Development and QC in Small Molecules. You will lead phase-appropriate analytical method development, validation and transfer, with oversight of CDMOs and collaboration across discovery, chemistry, QA and regulatory affairs.

The role requires a PhD with 3+ years (or MS/BS with extensive experience), hands-on SM analytical methods, and experience with cGMP and regulatory documentation. Travel up to 25% may be needed.

Qualifications

• PhD (3+ years) or MS (8+ years) or BS (10+ years) in biopharma or related field.
• Experience developing/validating/troubleshooting and transferring small-molecule analytical methods in cGMP.
• Experience overseeing CDMOs, CROs, and contract testing labs.
• Travel up to 25% may be required.

Responsibilities

• Develop and execute phase-appropriate analytical methods for small molecule LP intermediates.
• Provide technical leadership for method development, qualification, validation, transfer and lifecycle management.
• Develop testing methodologies for complex SM manufacturing, release, and stability testing with CDMOs.
• Oversee external labs to ensure timelines and quality standards are met.
• Lead investigations of method performance and CAPA actions; support regulatory submissions.
• Prepare GMP documents, SOPs, protocols, and reports for submissions and transfers.

Skills

Analytical development

Method development

Data analysis

Regulatory sciences

Cross-functional collaboration

Problem solving

QC testing

Education

PhD in Analytical Chemistry/Pharmaceutical Sciences

MS in relevant field

BS in relevant field

Tools

LC

GC

LC-MS/MS

NMR

Karl Fischer

Spectroscopy

Job description

Immunome, Inc. in Bothell, WA seeks a Principal Scientist for Analytical Development and QC in Small Molecules. You will lead phase-appropriate analytical method development, validation and transfer, with oversight of CDMOs and collaboration across discovery, chemistry, QA and regulatory affairs.

The role requires a PhD with 3+ years (or MS/BS with extensive experience), hands-on SM analytical methods, and experience with cGMP and regulatory documentation. Travel up to 25% may be needed.