layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Manager, External Manufacturing Operations at Immunome | LAYIQ

Provide day-to-day oversight of assigned suppliers, serving as a primary point of contact and facilitating effective coordination between Immunome and its external partners.
Participate in and, as appropriate
, lead Virtual Management Teams (VMTs) comprising
Quality, Product Supply, Technical Development, Regulatory, and other cross-functional stakeholders. Support alignment of priorities, deliverables, and key communications with CDMOs.
Coordinate and conduct well-organized and documented meetings internally and with assigned external suppliers. Monitor progress against established plans, including pre-campaign preparation, manufacturing operations, release activities, and
logistics.
Identify potential delays and risks and work with internal and external stakeholders to support timely resolution.
Develop a thorough understanding of Immunome’s manufacturing processes. Participate in technical reviews of master and executed batch records, specifications, investigations, change controls, and other manufacturing documentation, as required.
Monitor supplier performance through established Key Performance Indicators (KPIs) and work with internal stakeholders and external partners to identify and implement opportunities for improvement. Participate in periodic Business Review Meetings and other supplier governance forums.
Maintain understanding of assigned suppliers’ systems, capabilities, capacities, requirements, and business practices. Escalate significant operational, supply, quality, or relationship risks to leadership, as appropriate.
Collaborate with Legal and External Manufacturing leadership in the development and negotiation of service agreements, statements of work, and other contractual arrangements.
Partner with External Manufacturing leadership, Finance, and Project Management to monitor spending against budget, review CDMO invoicing for accuracy and alignment with contractual terms and communicate significant cost variances in a timely manner.
Provide clear and timely updates to External Manufacturing leadership and cross-functional stakeholders regarding manufacturing progress, risks, priorities, and issues requiring attention or decision-making.
Support technology transfers, supplier sourcing and qualification activities, as required.
Participate in the development and periodic review of manufacturing and supply risk assessments and support implementation of appropriate risk mitigation plans.
Contribute to the development and continuous improvement of processes, tools, and ways of working that support effective management of Immunome’s external manufacturing network.
Support manufacturing data collection, trending, and analysis, including the preparation of continuous process verification (CPV) summaries and report drafts, as required.

Manager, External Manufacturing Operations

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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