Manager CMC Program Operations

Role: CMC Program Operations Manager leading digital transformation and operational excellence in biopharma, specifically within cell & gene therapy development. Responsibilities: develop and maintain integrated project plans, design AI-enabled tools to automate reporting and risk management, oversee cross-functional coordination with Regulatory, Manufacturing, Quality, and Supply Chain teams, and track regulatory commitments. Drive process modernization through digital solutions, establish standardized workflows, and lead operational projects to improve transparency and efficiency. Requirements: Bachelor’s in a relevant field; 6+ years in biopharma/life sciences with at least 2 years in CMC or operations project management; strong skills in project management software (MS Project, Smartsheet), and AI/automation tools (generative AI, low-code platforms, scripting); working knowledge of GMP, quality systems, supply chain, regulatory landscape in cell & gene therapy. Preferred: PMP certification, hands-on experience deploying AI tools for operational reporting. HighValue: focus on CMC development for cell & gene therapies, digital tool deployment, risk management, cross-functional collaboration, fast-paced environment. WorkSetup: not specified; physical requirements N/A.