Senior Manager, Drug Product Technical Operations

Build, lead, and coach a high-performing Technical Operations Specialists team, emphasizing culture, performance, inclusion, and succession.,Provide daily manufacturing support, including cGMP, safety, and technical execution coaching.,Lead operational readiness for new product introductions and tech transfers (process recipes, master data, components, sampling plans).,Collaborate with cross-functional teams (MS&T, QA, Engineering, Supply Chain) for validation, process design, and launch.,Manage eBR/MES systems, including master batch records, recipes, change management, data integrity, and error reduction.,Drive development and use of GPT/AI tools for cycle time reduction and error mitigation (documentation assistants, line setup guides, KPI dashboards).,Sponsor governance, validation, and risk management for AI/GPT adoption, tracking ROI and user adoption.,Maintain high standards in deviations, change controls, risk assessments, sampling plans, and CAPA closure.,Ensure inspection readiness through evidence, storyboards, and SME preparedness; participate in mock audits.,Align operational controls and documentation with regulatory requirements.,Lead KPI reviews, performance monitoring (SQDCP), tiered governance, and root cause resolution.,Champion operational excellence (Lean/Six Sigma, 5S, kaizen, standard work, digital analytics).,Provide flexible coverage, including 24/7 on-call support for troubleshooting and risk mitigation.

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Bachelor's Degree

Must provide flexible coverage including 24/7 on-call support.,Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law, meaning only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible.