Director of Manufacturing

Job Responsibilities: Own the technical and process side of the CMO relationship: technology transfer, process development, and process validation strategy (IQ/OQ/PQ), ensuring processes are robust, transferable, and audit-ready Lead NPI from R&D design handoff through CMO production ramp, translating design intent into manufacturable, CMO-executable work instructions and process specs Own mfg. process KPIs (yield, scrap, first-pass quality, process capability) and drive corrective action at the process level when performance drifts Drive Lean Manufacturing and Six Sigma initiatives across the CMO network: waste reduction, process capability improvement, and continuous improvement programs at partner sites Partner with Supply Chain on capacity planning, production scheduling, and single-source risk mitigation, providing the technical input that informs sourcing and dual-sourcing decisions Conduct regular CMO site visits for floor-level process troubleshooting and technology transfer execution Partner closely with the COO on R&D priorities, resourcing, and roadmap execution Lead design transfer governance: define the stage-gate criteria a design must meet before release to a CMO for production Serve as the bridge between R&D and manufacturing, resolving design-for-manufacturability issues before they become process nonconformances Flag process drift or capability concerns at CMO sites to Quality between periodic audits, supporting root cause from the manufacturing/process side Support technology transfer and validation documentation that feeds CMO qualification and requalification, which Quality owns Provide technical/process input into CMO capacity, scheduling, and sourcing decisions owned by Collaborate on single-source risk assessments, contributing the process-transferability view to dual-sourcing decisions Build long-term manufacturing strategy as the company scales: when to add CMOs, when to bring select processes in-house, and how to structure the network for growth