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Contract: Manager, CMC Stability Management and Analysis

Immunome, Inc.
CompanyImmunome, Inc.
CategoryOperations & Admin
LocationBothell
RemoteOn-site (inferred)
EmploymentNot stated
LevelManager
SalaryNot stated by the employer
Posted30 Jun 2026
Last verified9 Aug 2026
SourceEmployer ATS (greenhouse)
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Description
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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be responsible for maintaining stability pull schedules, data review, and vendor oversight activities across mAb intermediate, drug substance, and drug product.   The successful consultant will bring practical expertise in GMP stability operations, biologics and large-molecule stability requirements, understanding of ADC stability indicating assays and outsourced laboratory management. This position requires a hands-on program manager who can translate technical and regulatory expectations into actionable plans, manage timelines and risks across external partners, and ensure stability deliverables are met.   Responsibilities Study Execution and Operational Oversight   Review stability protocols for long-term  and  accelerated  studies.   Create and  maintain  stability plans, master schedules, pull calendars , and study  trackers across multiple development programs.   Oversee execution of stability studies and ensure  timely  sample pulls, testing initiation, data delivery, and escalation of schedule or quality risks.     Data Review, Trending, and Technical Assessment   Review stability data for completeness, accuracy, data integrity, trend behavior, specification compliance, and consistency with expected product quality attributes.   Support evaluation of OOS/OOT results  and  atypical trends.   Prepare stability summaries, trend reports, shelf-life assessments, retest/expiry recommendations, and technical risk assessments to support program decision-making.     Qualifications Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or  a related  field.   8+ years of experience in stability, QC, Analytical Development, CMC, or technical operations within the biotechnology or biopharmaceutical industry , or equivalent.   Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules; ADC experience preferred.   Hands-on experience with stability data review, trending , shelf -life assessment .   Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies.   Working knowledge of GMP requirements, data integrity expectations, ICH stability guidance, and regulatory expectations for  biologics  stability studies.   Contract or consultant experience in a matrixed biotech environment preferred.     Knowledge and Skills In-depth understanding of  biologics  stability program management,