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Bothell, Washington, United States
Posted · 20.09.2026
Greenhouse (US)

# Principal Scientist, Analytical Development and QC, Small Molecule

Immunome, Inc.

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is&nbsp;seeking&nbsp;an experienced and collaborative Principal Scientist, Analytical Development and QC, Small Molecule to support our small molecule programs at various stages of development.&nbsp;&nbsp; The successful candidate will bring deep&nbsp;expertise&nbsp;in phase-appropriate small molecule analytical&nbsp;methods,&nbsp;development validation, transfer, and outsourced development models. Reporting to the Director, Analytical Development &amp; QC, this individual-contributor role will develop complex analytical methods, resolve technical issues, work collaboratively with internal and external stakeholders and advance Immunome's oncology pipeline.&nbsp;&nbsp;In addition, this role will be part of a team to build and enhance internal analytical development capabilities, including method development, validation, and transfer processes. The ideal candidate will have a strong background in developing complex analytical methods spanning characterization and QC testing, experience in CDMO interactions, and familiarity with cGMP and authoring analytical documents for regulatory submissions.&nbsp;&nbsp; Responsibilities Develop and execute phase-appropriate analytical methods for small molecule Linker payload (LP) intermediate, including specifications and control strategies.&nbsp;&nbsp; Provide technical leadership for method development, qualification, validation, transfer, troubleshooting, and lifecycle management across various techniques such as LC, GC, LC-MSMS, Karl Fischer, and spectroscopy.&nbsp;&nbsp; Develop robust analytical testing methodologies to support complex small molecule manufacturing, characterization,&nbsp;release&nbsp;and stability testing,&nbsp;on-site or in collaboration with Contract Development/Manufacturing Organization (CDMO),&nbsp; Oversee and manage relationships with external testing labs ensuring alignment with project timelines, quality standards, and regulatory requirements.&nbsp;&nbsp; Lead investigations of method performance, manufacturing issues, deviations, and OOS/OOT results; root-cause analysis, corrective actions, and risk-based recommendations.&nbsp;&nbsp; Assume Analytical Lead responsibilities for Immunome pipeline programs,&nbsp;providing&nbsp;scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.&nbsp;&nbsp; Participate in the creation of essential documentation (SOPs, protocols, reports) to support GMP activities, regulatory submissions,&nbsp;and method transfers.&nbsp;&nbsp; Stay informed of emerging trends in analytical development and evolving regulatory requirements, integrating these into the company’s development and QC strategy.&nbsp;&nbsp; Work closely with cross-functional teams, including discovery and process chemistry, quality assurance, virtual management&nbsp;team&nbsp;and regulatory affairs to ensure alignment of project goals and&nbsp;objectives.&nbsp;&nbsp; Author and review analytical sections of CMC documents and regulatory submissions (IND/CTA, NDA/MAA, CTD), including methods, validation, specifications, impurities, and stability. Review batch records and batch release documentation.&nbsp;&nbsp; Establish analytical and stability plans, impurity-control approaches, reference standard programs, and comparability strategies supporting scale-up and technology transfer.&nbsp;&nbsp; Assist&nbsp;in&nbsp;establishing&nbsp;internal capabilities for small molecule analytical&nbsp;method&nbsp;development and product characterization.&nbsp;&nbsp; &nbsp;&nbsp; Qualifications A minimum of a&nbsp;Ph.D.&nbsp;With 3&nbsp;years' experience,&nbsp;M.S. with 8 years, or B.S. with 10 years in the biopharmaceutical industry, or equivalent combination of experience and education. A degree&nbsp;in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related&nbsp;fields&nbsp;are&nbsp;preferred.&nbsp;&nbsp;&nbsp; Demonstrated experience developing,&nbsp;validating, troubleshooting, and transferring analytical methods for small molecule compounds in cGMP environments, managing stability&nbsp;programs,&nbsp;and supporting global regulatory submissions.&nbsp;&nbsp; Experience providing technical oversight of CDMOs, CROs, and contract testing laboratories.&nbsp;&nbsp; Experience in Linker Payload (LP) product characteristics including understanding of conjugate type and linker-payload properties on product quality is highly preferred.&nbsp;&nbsp; Position may require occasional evening and/or weekend commitment.&nbsp;&nbsp; Position may require domestic and/or international travel, up to 25%.&nbsp; &nbsp;&nbsp; Knowledge and Skills Hands-on&nbsp;expertise&nbsp;with LC, GC, LC-MSMS, NMR, DVS, Karl Fischer, spectroscopy, impurity profiling, and degradation studies&nbsp;&nbsp; Good understanding of small molecule control strategies, including specifications, impurities, stability, reference standards, and comparability.&nbsp;&nbsp; Strong scientific judgment and technical problem-solving skills for complex analytical and manufacturing challenges.&nbsp;&nbsp; Working knowledge of pharmacopoeias, cGMP, data integrity, analytical lifecycle management, and applicable ICH and compendial guidance.&nbsp;&nbsp; Excellent written and verbal communication skills for diverse technical and non-technical audiences.&nbsp;&nbsp; Exceptional organizational skills and the ability to work with minimum supervision in a fast-paced, dynamic biotech environment.&nbsp;&nbsp; Solution-oriented problem-solving skills, with the capacity to manage multiple projects and prioritize in a fast-paced setting.&nbsp;&nbsp; Commitment to scientific excellence, quality culture, data integrity, and technical mentorship.&nbsp;&nbsp; &nbsp;&nbsp;Washington State Pay Range$170,000&mdash;$196,227 USDE/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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