Manager, Clinical Supply Operations
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
Operations
Position Overview:
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), focusing on supply of finished drug products (FDP) and may support biologics and small molecule programs.
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs; primary liaison between CDMO and Immunome.
- Lead one or more Virtual Management Teams (VMTs) to keep deliverables on track and align priorities/communications with the CDMO.
- Conduct meetings with CDMOs; ensure progress tracks to plan (label development, production readiness, batch ops, release, logistics); proactively address delays.
- Participate in Clinical Operations study teams on trial design, demand parameters, and protocol amendments; may support randomization scheme development.
- Partner with Supply Chain Planning to analyze inventory and plan batch production; recommend labeling/packaging schedule changes based on study progress.
- Support technical reviews of master/executed batch records, specifications, investigations, and change requests.
- Coordinate with Global Logistics and Materials Management for on-time shipments and clinical site drug availability.
- Collaborate with management and Legal on proposals and service agreements.
- Monitor spending vs. budget; ensure accurate CDMO invoicing and communicate variances.
- Maintain knowledge of CDMO systems/capabilities/capacities/business practices.
- Monitor CDMO performance via KPIs; drive improvements; lead/participate in business review meetings.
- Support sourcing, and audit/qualification of new CDMOs.
- Support technology transfers, process improvements/validations, and regulatory submission reviews.
- Support network risk assessments and supply risk mitigation.
Qualifications:
- Minimum 5 years overseeing outsourced cGMP clinical packaging and labeling operations in biotech/pharma (or equivalent).
- APICS certification a plus.
- Domestic/international travel up to 25%; occasional evening/weekend commitment.
Knowledge and Skills:
- Strong organizational, communication, and collaboration skills.
- Familiarity with cGMP clinical labeling/packaging (highly potent product experience a plus).
- Experience with IRT/RTSM systems.
- ERP experience desired.
- Quality systems knowledge; direct experience with deviation investigations, change controls, corrective actions.
- Negotiation skills and familiarity with contractual terms.
- Comfortable with ambiguity; adapt quickly to changing priorities.
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), focusing on supply of finished drug products (FDP) and may support biologics and small molecule programs.
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs; primary liaison between CDMO and Immunome.
- Lead one or more Virtual Management Teams (VMTs) to keep deliverables on track and align priorities/communications with the CDMO.
- Conduct meetings with CDMOs; ensure progress tracks to plan (label development, production readiness, batch ops, release, logistics); proactively address delays.
- Participate in Clinical Operations study teams on trial design, demand parameters, and protocol amendments; may support randomization scheme development.
- Partner with Supply Chain Planning to analyze inventory and plan batch production; recommend labeling/packaging schedule changes based on study progress.
- Support technical reviews of master/executed batch records, specifications, investigations, and change requests.
- Coordinate with Global Logistics and Materials Management for on-time shipments and clinical site drug availability.
- Collaborate with management and Legal on proposals and service agreements.
- Monitor spending vs. budget; ensure accurate CDMO invoicing and communicate variances.
- Maintain knowledge of CDMO systems/capabilities/capacities/business practices.
- Monitor CDMO performance via KPIs; drive improvements; lead/participate in business review meetings.
- Support sourcing, and audit/qualification of new CDMOs.
- Support technology transfers, process improvements/validations, and regulatory submission reviews.
- Support network risk assessments and supply risk mitigation.
Qualifications:
- Minimum 5 years overseeing outsourced cGMP clinical packaging and labeling operations in biotech/pharma (or equivalent).
- APICS certification a plus.
- Domestic/international travel up to 25%; occasional evening/weekend commitment.
Knowledge and Skills:
- Strong organizational, communication, and collaboration skills.
- Familiarity with cGMP clinical labeling/packaging (highly potent product experience a plus).
- Experience with IRT/RTSM systems.
- ERP experience desired.
- Quality systems knowledge; direct experience with deviation investigations, change controls, corrective actions.
- Negotiation skills and familiarity with contractual terms.
- Comfortable with ambiguity; adapt quickly to changing priorities.