Jobs and Careers

Associate Director, Quality Control, Biologics

United Statesfull_timeVerifiedPosted 2 Jul 2026

💰 $203,985/yr($177,813/yr – $203,985/yr)

About the role

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 a highly experienced and strategic Associate Director, Quality Control, Biologics to lead QC strategy and execution in support of our biologics and ADC portfolio. This role will be responsible for oversight of GMP QC activities, including analytical method transfer, qualification and validation, release and stability testing, investigation support, external testing lab management, and QC documentation supporting clinical development and regulatory submissions.

The successful candidate will bring deep technical expertise in biologics and ADC analytical testing, a strong working knowledge of GMP requirements and global regulatory expectations, and the leadership skills necessary to manage cross-functional and external partners. This position offers a highly visible opportunity to build scalable QC processes and ensure Immunome’s products are tested with scientific rigor, operational discipline, and patient-centered quality.

Responsibilities

QC Strategy and Governance

Develop and implement phase-appropriate QC strategies for biologics and ADC programs across drug substance and drug product development, release, and stability.

Provide scientific, technical, and GMP oversight for QC testing, method lifecycle activities, specifications, reference standards and critical reagent strategies.

Contribute to the long-term vision for Immunome’s QC capabilities, including evaluation of technologies, systems, and external partnerships to support portfolio growth.

Program Oversight and Execution

Oversee execution of GMP and non-GMP analytical testing for intermediates, drug substance, drug product, and stability samples in collaboration with CTLs and CDMOs.

Lead review and interpretation of QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports.

Serve as the QC representative on cross-functional program teams, ensuring QC deliverables are aligned with CMC timelines.

External Laboratory and Partner Management

Manage external contract testing laboratories and CDMO QC functions to ensure timely, compliant, and high-quality study execution.

Oversee method transfer, qualification, validation, verification, and troubleshooting activities across external laboratories.

Establish expectations for documentation quality, sample management, stability pulls, and communication cadence with external partners.

Regulatory and Documentation Support

Author and review QC-related SOPs, protocols, validation and qualification plans, method transfer reports, specifications, CoAs, stability summaries, and regulatory submission content.

Support preparation of IND, BLA, CTD, and other global regulatory submissions, including responses to health authority questions related to QC and analytical controls.