Position OverviewThe 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). This role centers on managing the supply of finished drug products (FDP) and may support a wide range of projects, including biologics and small molecule programs.
Responsibilities- Serve as the Supplier Relationship Manager (SRM) for specified CDMOs offering clinical packaging and distribution 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 (e.g., label development, production readiness, batch operations, release activities and logistics, etc.). Proactively address delays to avoid impact on supply.
- Participate in Clinical Operations study team(s) to stay current on trial design, demand parameters and protocol amendments. May support the development of randomization schemes for open and blind clinical studies.
- Partner with Supply Chain Planning to analyze inventory levels and plan batch production. Recommend changes to labeling and packaging schedules based on study progress.
- Support technical reviews of master and executed batch records, specifications, investigations, and change requests as required.
- Work with Global Logistics and Materials Management to ensure on-time shipments and drug availability at all clinical sites.
- Collaborate with department management and Legal to support the development and negotiation of proposals and service 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 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.
Qualifications- Minimum of 5 years of industry experience with direct responsibility overseeing outsourced cGMP clinical packaging and labeling operations or equivalent.
- APICS certification a plus.
- Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.
Knowledge and Skills- Strong organizational, communication, and collaboration skills.
- Closely familiar with cGMP clinical labeling and packaging operations. Experience with highly potent products is a plus.
- Experience with IRT/RTSM systems supporting inventory and supply management functionality.
- Close familiarity or expertise working with an enterprise level planning system (ERP) is desired.
- Well-versed in Quality systems, and some direct experience with cGMP deviation investigations, change controls, and corrective actions.
- Possess negotiation skills and be familiar with general contractual terms.
- Comfortable with ambiguity and uncertainty; must adapt swiftly with focus on delivering to the business needs as priorities develop/change.
Washington State Pay Range
$144,829-$169,616 USD
