Manager, Clinical Supply Operations

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.

Responsibilities

• Serve as the Supplier Relationship Manager (SRM) for specified CDMOs offering clinical packaging and distribution services.
• Serve as the primary liaison between the CDMO and Immunome.
• Lead one or more Virtual Management Teams (VMTs) ensuring Immunome’s deliverables stay on track, and internal alignment on priorities and key communications with the CDMO.
• Conduct well-organized meetings with CDMOs.
• Ensure CDMO progress is tracking to plan (e.g., label development, production readiness, batch operations, release activities and logistics, etc.).
• Proactively address delays to avoid impact on supply.
• Participate in Clinical Operations study team(s) to stay current on trial design, demand parameters and protocol amendments.
• May support the development of randomization schemes for open and blind clinical studies.
• Partner with Supply Chain Planning to analyze inventory levels and plan batch production.
• Recommend changes to labeling and packaging schedules based on study progress.
• Support technical reviews of master and executed batch records, specifications, investigations, and change requests as required.
• Work with Global Logistics and Materials Management to ensure on-time shipments and drug availability at all clinical sites.
• Collaborate with department management and Legal to support the development and negotiation of proposals and service agreements.
• Monitor and track spending against budget.
• Ensure CDMO invoicing is accurate and aligned with contractual terms.
• Ensure that unexpected cost variances are communicated quickly.
• Maintain comprehensive knowledge of the CDMO’s systems, capabilities, capacities, requirements, and business practices.
• Monitor CDMO performance through Key Performance Indicators (KPIs) and drive improvements aligned with Immunome’s expectations.
• Lead or participate in periodic Business Review Meetings.
• Support sourcing efforts, and the audit and qualification of new CDMOs.
• Support technology transfers, process improvements, process validations, and regulatory submission reviews.
• Support network risk assessments and the development and implementation of measures to mitigate supply risks.

Qualifications

• Minimum of 5 years of industry experience with direct responsibility overseeing outsourced cGMP clinical packaging and labeling operations or equivalent.
• APICS certification a plus.
• Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.

Skills

• Strong organizational, communication, and collaboration skills.
• Closely familiar with cGMP clinical labeling and packaging operations.
• Experience with highly potent products is a plus.
• Experience with IRT/RTSM systems supporting inventory and supply management functionality.
• Close familiarity or expertise working with an enterprise level planning system (ERP) is desired.
• Well-versed in Quality systems, and some direct experience with cGMP deviation investigations, change controls, and corrective actions.
• Possess negotiation skills and be familiar with general contractual terms.
• Comfortable with ambiguity and uncertainty; must adapt swiftly with focus on delivering to the business needs as priorities develop/change.

Pay

Washington State Pay Range $144,829 - $169,616 USD