Manager, External Manufacturing Operations

Manager, External Manufacturing Operations

Bothell, Washington, United States

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 Manager, External Manufacturing Operations,is responsible for ensuring Immunome’s supply requirements are met through the coordination and oversight of activities performed by external suppliers, including Contract Development and Manufacturing Organizations (CDMOs) and other third-party service providers. The Manager will serve as a key point of contact for assigned external partners and collaborate cross-functionally to ensure the effective execution of activities in support of clinical and commercial programs.

The role will initially focus on small molecule programs, with the opportunity to supportadditionalmodalities as Immunome’s portfolio and external manufacturing network evolve and expand.

Responsibilities

• Provide day-to-day oversight of assigned suppliers, serving as a primary point of contact and facilitating effective coordination between Immunome and its external partners.
• Participate in and, as appropriate , lead Virtual Management Teams (VMTs) comprising Quality, Product Supply, Technical Development, Regulatory, and other cross-functional stakeholders. Support alignment of priorities, deliverables, and key communications with CDMOs.
• Coordinate and conduct well-organized and documented meetings internally and with assigned external suppliers. Monitor progress against established plans, including pre-campaign preparation, manufacturing operations, release activities, and logistics . Identify potential delays and risks and work with internal and external stakeholders to support timely resolution.
• Develop a thorough understanding of Immunome’s manufacturing processes. Participate in technical reviews of master and executed batch records, specifications, investigations, change controls, and other manufacturing documentation, as required .
• Monitor supplier performance through established Key Performance Indicators (KPIs) and work with internal stakeholders and external partners to identify and implement opportunities for improvement. Participate in periodic Business Review Meetings and other supplier governance forums.
• Maintain understanding of assigned suppliers’ systems, capabilities, capacities, requirements, and business practices. Escalate significant operational, supply, quality, or relationship risks to leadership, as appropriate .
• Collaborate with Legal and External Manufacturing leadership in the development and negotiation of service agreements, statements of work, and other contractual arrangements.
• Partner with External Manufacturing leadership, Finance, and Project Management to monitor spending against budget, review CDMO invoicing for accuracy and alignment with contractual terms and communicate significant cost variances in a timely manner .
• Provide clear and timely updates to External Manufacturing leadership and cross-functional stakeholders regarding manufacturing progress, risks, priorities, and issues requiring attention or…