Principal Scientist, Analytical Development and QC, Small Molecule
Immunome, Inc.Bothell, Washington, United States · Posted TodayDescription
Company Overview
Position Overview
Immunome is seeking an experienced and collaborative Principal Scientist, Analytical Development and QC, Small Molecule to support our small molecule programs at various stages of development.
The successful candidate will bring deep expertise in phase-appropriate small molecule analytical methods, development validation, transfer, and outsourced development models. Reporting to the Director, Analytical Development & 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. 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.
Responsibilities
- Develop and execute phase-appropriate analytical methods for small molecule Linker payload (LP) intermediate, including specifications and control strategies.
- 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.
- Develop robust analytical testing methodologies to support complex small molecule manufacturing, characterization, release and stability testing, on-site or in collaboration with Contract Development/Manufacturing Organization (CDMO),
- Oversee and manage relationships with external testing labs ensuring alignment with project timelines, quality standards, and regulatory requirements.
- Lead investigations of method performance, manufacturing issues, deviations, and OOS/OOT results; root-cause analysis, corrective actions, and risk-based recommendations.
- Assume Analytical Lead responsibilities for Immunome pipeline programs, providing scientific guidance on data analysis and interpretation, contributing to the preparation of regulatory submissions and technical reports.
- Participate in the creation of essential documentation (SOPs, protocols, reports) to support GMP activities, regulatory submissions, and method transfers.
- Stay informed of emerging trends in analytical development and evolving regulatory requirements, integrating these into the company’s development and QC strategy.
- Work closely with cross-functional teams, including discovery and process chemistry, quality assurance, virtual management team and regulatory affairs to ensure alignment of project goals and objectives.
- 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.
- Establish analytical and stability plans, impurity-control approaches, reference standard programs, and comparability strategies supporting scale-up and technology transfer.
- Assist in establishing internal capabilities for small molecule analytical method development and product characterization.
Qualifications
- A minimum of a Ph.D. With 3 years' experience, M.S. with 8 years, or B.S. with 10 years in the biopharmaceutical industry, or equivalent combination of experience and education. A degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related fields are preferred.
- Demonstrated experience developing, validating, troubleshooting, and transferring analytical methods for small molecule compounds in cGMP environments, managing stability programs, and supporting global regulatory submissions.
- Experience providing technical oversight of CDMOs, CROs, and contract testing laboratories.
- Experience in Linker Payload (LP) product characteristics including understanding of conjugate type and linker-payload properties on product quality is highly preferred.
- Position may require occasional evening and/or weekend commitment.
- Position may require domestic and/or international travel, up to 25%.
Knowledge and Skills
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