Senior Manager, Commercial Supply 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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Senior Manager will play a key role in ensuring reliable, compliant, and on-time supply of finished commercial drug products through cross-functional collaboration and oversight of critical business processes and cGMP operations performed at Contract Manufacturing Organizations (CMOs). In addition, this role will play a central role in supporting product launch readiness and execution.

Responsibilities

• Serve as the Supplier Relationship Manager (SRM) for specified CDMOs offering labeling, packaging, and related 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 Proactively address delays to avoid impact on supply.


• Will participate in Planning, CMC, Commercial, launch readiness, and other forums as required.


• Lead the design, development, approval, and implementation of new and revised commercial artwork, labeling and packaging in close collaboration with Commercial, Regulatory, and Quality.


• Support serialization development and implementation, and the evaluation, selection, and implementation of other key anti-counterfeiting features.


• Lead the planning, execution, and oversight of GMP process validation activities, partnering with Regulatory and Quality colleagues to ensure compliance; may draft Validation Master Plans/protocols and summary reports.


• Provide 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 sites/distribution centers.


• Collaborate with department management and Legal to support the development and negotiation of proposals and service and commercial-level 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 detailed launch planning activities, internally and at the CDMOs.


• 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.


• Author and revise Product Supply related Standard Operating Procedures (SOPs). Provide packaging and labeling oversight support to clinical-stage programs, as needed.

Qualifications

• Minimum of 8 years of industry experience with direct responsibility overseeing cGMP commercial pharmaceutical or biotech product labeling and packaging operations.


• Bachelor’s degree is required.

Knowledge and Skills

• Strong organizational, communication, and cross-functional collaboration skills, with the ability to lead complex workstreams.


• Demonstrated proficiency in cGMP commercial labeling and packaging requirements and operations.


• Proven experience leading implementation of commercial artwork, labeling, and packaging, including design considerations; experience with highly potent products is a plus.


• Demonstrated experience supporting and executing commercial product launches.


• Solid working knowledge of Quality systems and processes, including cGMP investigations, change control, and corrective and preventive actions (CAPA).


• 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 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.

E/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).