Immunome, Inc. · 7 hours ago
Senior Manager, Commercial Supply Operations
Bothell, Washington, United States
Full-time
Onsite
Senior Level, Lead/Staff
$165K/yr - $190K/yr
8+ years expImmunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The Senior Manager will ensure 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).
BiopharmaBiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Preferred
APICS certification a plus
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
Company data provided by crunchbase