Senior Manager, Commercial Supply Operations

Role Summary

The Senior Manager, Commercial Supply Operations is responsible for 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). The role also supports 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

• Required: Minimum of 8 years of industry experience with direct responsibility overseeing cGMP commercial pharmaceutical or biotech product labeling and packaging operations.
• Required: Bachelor’s degree.

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.
• APICS certification a plus.

Additional Requirements

• Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.