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. 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 a highly experienced and collaborative Senior Manager, Analytical Development and QC, Small Molecule to lead analytical method development, validation, and quality control activities supporting our small molecule programs from early development through regulatory submissions and commercialization.

The successful candidate will bring deep technical expertise in small molecule analytical chemistry, understanding of cGMP and ICH expectations, and proven experience operating in an outsourced development model with CDMOs and contract testing laboratories. Reporting to the Director, Analytical Development QC, this individual will shape Immunome’s small molecule analytical development and QC strategy and advance our oncology pipeline.

Responsibilities

Strategic Leadership Develop and execute phase-appropriate analytical development and QC strategies for ADC linker payload components, small molecule intermediates, and drug substance, including specifications and control strategies. Provide technical leadership for analytical method development, qualification, validation, and lifecycle management. Establish and maintain analytical development plans, stability strategies, and comparability/bridging approaches to support process changes, scale-up, and technology transfers.

Program Oversight and Execution Manage execution of analytical testing to support in-process controls, release, stability, and characterization. Partner with cross-functional leaders across CMC, Process Chemistry, Manufacturing, QA, and Regulatory to ensure seamless integration of analytical deliverables within development timelines. Critically review and interpret analytical data to troubleshoot methods, manufacturing issues, investigate OOS/OOT results, and drive root-cause analysis and CAPA activities.

Support review of batch records from an analytical perspective. Vendor and Partner Management Manage and provide technical oversight of CDMOs, and contract testing labs to ensure high-quality, timely, and compliant method development, validation, and routine QC testing. Lead scope definition, issue resolution, deviations, change controls, and inspection readiness activities.

, IND/CTA, NDA/MAA, CTD), including method descriptions, validation summaries, specifications, and stability data. Support responses to analytical and quality-related questions from global health authorities and internal stakeholders. , ICH Q2, Q3, Q6A, Q7; USP/EP/JP).

Leadership and Collaboration Communicate complex analytical concepts, results, and recommendations clearly and effectively to diverse audiences. Contribute to building Immunome’s internal analytical capabilities and best practices, including evaluation of new technologies and analytical approaches where appropriate.

Qualifications

D. S. S.

with 12+ years.