Senior Manager, Commercial Supply Operations

Immunome, Inc.•Bothell, WA

3d•$165,048 - $189,885

About The Position

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.

Requirements

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.
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.

Nice To Haves

APICS certification a plus.

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.