Principal Scientist, Analytical Development and QC, Small Molecule

As Principal Scientist, Analytical Development and QC (Small Molecule), you will lead phase-appropriate analytical method development, validation, and transfer to support Immunome's oncology programs. You'll work cross-functionally to ensure regulatory readiness and robust QC testing, while expanding internal capabilities and maintaining cGMP-compliant practices. You drive technical excellence in complex methods and partner with CDMOs and labs to meet project timelines. This role offers impact across the Immunome pipeline and regulatory submissions.

• Develop phase-appropriate analytical methods for small molecule LP intermediates with defined specifications and control strategies
• Provide technical leadership for method development, qualification, validation, transfer, troubleshooting, and lifecycle management across LC, GC, LC-MS/MS, Karl Fischer, spectroscopy
• Develop robust testing strategies for manufacturing, characterization, release, and stability testing with internal or CDMO collaboration
• Oversee external testing labs, ensuring timely delivery and compliance with quality standards
• Lead investigations into method performance, manufacturing deviations, OOS/OOT, root-cause analysis, and corrective actions
• Serve as Analytical Lead for Immunome pipeline programs, guiding data interpretation and supporting regulatory submissions
• Create GMP-supporting documentation (SOPs, protocols, reports) and contribute to CMC sections of IND/CTA, NDA/MAA, CTD
• Establish analytical and stability plans, impurity-control strategies, reference standards, and comparability plans for scale-up and tech transfer
• Support building internal capabilities for small molecule analytics and product characterization
• Stay current with regulatory trends and integrate them into development and QC strategy
• Collaborate with discovery, process chemistry, QA, regulatory affairs, and management teams to align project goals
• Review batch records and release documentation for regulatory readiness

• Ph.D. with 3+ years, MS with 8 years, or BS with 10 years in biopharma or equivalent
• Experience developing, validating, troubleshooting, and transferring small molecule analytical methods in cGMP environments
• Experience with stability programs and global regulatory submissions support
• Experience overseeing CDMOs, CROs, and contract testing labs
• Knowledge of LP product characteristics and linker-payload concepts is highly preferred
• Willingness for occasional evening/weekend work and up to 25% travel

• Excellent written and verbal communication
• Strong scientific judgment and problem-solving
• Collaborative, cross-functional teamwork
• LC
• GC
• LC-MS/MS