Director, Quality Operations

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

The Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required.

Responsibilities

Quality Operations

• Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.
• Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
• Disposition clinical and commercial batches.
• Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products .
• Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed. <