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Bothell, Washington, United States
Posted · 20.09.2026
Greenhouse (US)

# Manager, External Manufacturing Operations

Immunome, Inc.

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,&nbsp;is responsible for&nbsp;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.&nbsp;&nbsp; The role will initially focus on small molecule programs, with the opportunity to support&nbsp;additional&nbsp;modalities as Immunome’s portfolio and external manufacturing network evolve and expand.&nbsp; Responsibilities Provide day-to-day oversight of assigned suppliers, serving as a primary point of contact and&nbsp;facilitating&nbsp;effective coordination between Immunome and its external partners.&nbsp;&nbsp; Participate in and, as&nbsp;appropriate, lead Virtual Management Teams (VMTs)&nbsp;comprising&nbsp;Quality, Product Supply, Technical Development, Regulatory, and other cross-functional stakeholders. Support alignment of priorities, deliverables, and key communications with CDMOs.&nbsp;&nbsp; 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&nbsp;logistics.&nbsp;Identify&nbsp;potential delays and risks and work with internal and external stakeholders to support&nbsp;timely&nbsp;resolution.&nbsp;&nbsp; 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&nbsp;required.&nbsp;&nbsp; Monitor supplier performance through established Key Performance Indicators (KPIs) and work with internal stakeholders and external partners to&nbsp;identify&nbsp;and implement opportunities for improvement. Participate in periodic Business Review Meetings and other supplier governance forums.&nbsp;&nbsp; Maintain understanding of assigned suppliers’ systems, capabilities, capacities, requirements, and business practices. Escalate significant operational, supply, quality, or relationship risks to leadership, as&nbsp;appropriate.&nbsp;&nbsp; Collaborate with Legal and External Manufacturing leadership in the development and negotiation of service agreements, statements of work, and other contractual arrangements. &nbsp;&nbsp; Partner with External Manufacturing leadership, Finance, and Project Management to&nbsp;monitor&nbsp;spending against budget, review CDMO invoicing for accuracy and alignment with contractual terms and communicate significant cost variances&nbsp;in a timely manner.&nbsp;&nbsp; Provide clear and&nbsp;timely&nbsp;updates to External Manufacturing leadership and cross-functional stakeholders&nbsp;regarding&nbsp;manufacturing progress, risks, priorities, and issues requiring attention or decision-making.&nbsp;&nbsp; Support technology transfers, supplier&nbsp;sourcing&nbsp;and qualification activities, as&nbsp;required.&nbsp;&nbsp; Participate in the development and periodic review of manufacturing and supply risk assessments and support implementation of&nbsp;appropriate risk&nbsp;mitigation plans.&nbsp;&nbsp; Contribute to the development and continuous improvement of processes, tools, and ways of working that support effective management of Immunome’s external manufacturing network.&nbsp;&nbsp; Support manufacturing data collection, trending, and analysis, including the preparation of continuous process verification (CPV) summaries and report drafts, as&nbsp;required.&nbsp;&nbsp; &nbsp;&nbsp; Qualifications Bachelor’s degree in biotechnology, biology, chemistry, chemical engineering, pharmaceutical sciences, or a related field&nbsp;required; an advanced degree is preferred.&nbsp;&nbsp; A minimum of 7&nbsp;years of relevant experience in the biotechnology or pharmaceutical industry, or&nbsp;an equivalent combination of work and education experience.&nbsp;&nbsp; Hands-on experience in&nbsp;small molecule&nbsp;manufacturing operations, process development, process engineering, or related activities.&nbsp;&nbsp; Experience working directly with CDMOs and successfully collaborating in a matrixed, cross-functional environment.&nbsp;&nbsp; Position requires domestic and international travel of up to approximately 25%, with occasional evening and/or weekend commitments based on manufacturing activities and business needs.&nbsp;&nbsp; &nbsp;&nbsp; Knowledge and Skills Strong organizational, communication, and collaboration skills, with the ability to effectively coordinate activities across internal functions and external partners.&nbsp;&nbsp; Working knowledge of cGMP requirements and pharmaceutical Quality Systems, including deviations, investigations, change controls, CAPAs, and batch disposition activities.&nbsp;&nbsp; Strong problem-solving skills, with the ability to&nbsp;identify&nbsp;manufacturing and supply risks, coordinate cross-functional input, and drive issues toward resolution.&nbsp;&nbsp; Working knowledge of service agreements, statements of work, and other contractual terms relevant to external manufacturing.&nbsp;&nbsp; Ability to&nbsp;operate&nbsp;effectively in a fast-paced and evolving environment, manage multiple priorities, and adapt as business needs&nbsp;change.&nbsp;&nbsp; Washington State Pay Range$108,969&mdash;$138,046 USDE/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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