Manager, Clinical Supply Operations
Immunome, Inc.
August 29, 2026
On-site
Bothell, WA
Operations
Position: Manager, Clinical Supply Operations
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs providing clinical packaging and distribution; act as primary liaison.
- Lead one or more Virtual Management Teams (VMTs) to keep deliverables on track and align priorities/communications with the CDMO.
- Run CDMO meetings; ensure progress tracks to plan (label development, production readiness, batch operations, release, logistics) and proactively address delays.
- Participate in Clinical Operations study team(s); stay current 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 changes to labeling/packaging schedules.
- 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 drug availability at clinical sites.
- Collaborate with department management and Legal on proposals and service agreements.
- Monitor spending vs. budget; ensure accurate CDMO invoicing and timely communication of variances.
- Maintain knowledge of CDMO systems/capabilities/capacities/requirements/business practices.
- Monitor CDMO performance via KPIs; drive improvements and support 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 (plus).
- Travel up to 25% (domestic/international) and occasional evening/weekend commitment.
Knowledge/Skills:
- Strong organizational, communication, and collaboration skills.
- Strong familiarity with cGMP clinical labeling/packaging (highly potent experience is a plus).
- Experience with IRT/RTSM; ERP planning system familiarity desired.
- Quality systems knowledge; experience with deviations, change controls, and CAPA.
- Negotiation skills; familiarity with contractual terms.
- Ability to work in ambiguity and adapt quickly.
Pay Range:
- $144,829 - $169,616 USD
Responsibilities:
- Serve as Supplier Relationship Manager (SRM) for specified CDMOs providing clinical packaging and distribution; act as primary liaison.
- Lead one or more Virtual Management Teams (VMTs) to keep deliverables on track and align priorities/communications with the CDMO.
- Run CDMO meetings; ensure progress tracks to plan (label development, production readiness, batch operations, release, logistics) and proactively address delays.
- Participate in Clinical Operations study team(s); stay current 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 changes to labeling/packaging schedules.
- 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 drug availability at clinical sites.
- Collaborate with department management and Legal on proposals and service agreements.
- Monitor spending vs. budget; ensure accurate CDMO invoicing and timely communication of variances.
- Maintain knowledge of CDMO systems/capabilities/capacities/requirements/business practices.
- Monitor CDMO performance via KPIs; drive improvements and support 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 (plus).
- Travel up to 25% (domestic/international) and occasional evening/weekend commitment.
Knowledge/Skills:
- Strong organizational, communication, and collaboration skills.
- Strong familiarity with cGMP clinical labeling/packaging (highly potent experience is a plus).
- Experience with IRT/RTSM; ERP planning system familiarity desired.
- Quality systems knowledge; experience with deviations, change controls, and CAPA.
- Negotiation skills; familiarity with contractual terms.
- Ability to work in ambiguity and adapt quickly.
Pay Range:
- $144,829 - $169,616 USD