Manager/Sr. Manager, Clinical Supply Operations

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

The Manager/Sr. Manager, Clinical Supply Operations, is responsible for meeting Immunome's supply requirements by enabling and overseeing cGMP operations performed at Contract Development and Manufacturing Organizations (CDMOs). This role centers on managing the supply of finished drug products (FDP) and may support a wide range of projects, including biologics and small molecule programs.

Responsibilities

• Serve as the Supplier Relationship Manager (SRM) for specified CDMOs offering clinical labeling, 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., carton and label design, label text, batch operations and release activities, logistics, etc.). Proactively address delays to avoid impact on supply.
• May participate at the Clinical Operations study team level to understand overall trial design, drug demand, protocol, and changes. May support the development of randomization schemes for open and blinded clinical studies.
• Support the Planning team in obtaining and analyzing inventory levels, and planning 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.
• Support 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.

Other Responsibilities and Projects:

• 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.
• Must have substantial demonstrated work experience with IRT/RTSM systems supporting inventory and supply management functionality.

Knowledge and Skills

• Strong organizational, communication, and collaboration skills.
• Must be closely familiar with cGMP clinical labeling and packaging operations. Experience with highly potent products is a plus.
• Expertise working with an enterprise level planning system (ERP) is desired.
• Must be versed in Quality systems, and have experience with cGMP deviation investigations, change controls, and corrective actions.
• Must possess negotiation skills and be familiar with general contractual terms.
• Must be comfortable with ambiguity and uncertainty; must adapt swiftly with focus on delivering to the business needs as priorities develop/change.
• Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.
• APICS certification a plus.

Washington State Pay Range

$154,017-$180,300 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.