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Manager, Label Operations

$103.56k - $125.5k

Scorpion Therapeutics

Shift: Wednesday–Saturday, Onsite Night Shift, 6:00 p.m.–4:30 a.m. Responsibilities Implement/manage site Label Operations at S12 Summit West (Summit, NJ) per BMS policies/standards/procedures and Global cGMPs. Supervise label control activities for Cell Therapy Development and Operations (CTDO); lead label management and align with global/regional regulatory requirements. Develop/maintain a GMP-compliant clinical and commercial label issuance and control process; ensure continuous improvement. Oversee daily activities; act as site lead for clinical/commercial label management system implementation initiatives; support projects within timelines. Ensure timely issuance of in-process and final product labels; coordinate deliverables for launches/market and quality initiatives. Lead SOP creation/review/update and GMP documentation/batch record archival; perform gap assessments and recommend solutions. Maintain quality metrics; collaborate on corrective actions for quality system issues. On-board requirements/training for new staff; coach/mentor team (training, discipline, problem solving, professional growth). Support electronic label issuance/control systems. Perform supplemental investigations/projects as required by management. Qualifications & Skills Advanced GMP, Quality, compliance, and risk management knowledge. Ability to interpret issues and communicate clearly; author and critically review reports; apply Quality Risk Management. Action-oriented, customer-focused; strong decision-making, problem solving, planning, resource allocation, conflict management. Lead teams/cross-functional projects; coach talent; independent mindset and tenacity. Proficient with PC/Microsoft Office; minimal direction; manage experienced professionals. Minimum Requirements B.S. degree (or equivalent education/experience); 5+ years relevant experience; 2+ years leadership. Compensation/Benefits (if eligible) $103,560–$125,495; health/dental/vision, wellbeing support, 401(k), disability/life/other insurance, and paid time off (details vary by eligibility). #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 2 days ago
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