CMC Technical Authoring Manager – Global Technical Operations
Core
Author and deliver submission-ready Chemistry, Manufacturing and Controls (CMC) content for biologics marketing applications and post-approval submissions, integrating scientific insight with AI-enabled tools.
Role type
Manager, CMC Technical Authoring
Builds
Regulatory submissions and responses to Health Authority questions for biologic products
Domain
Biopharmaceuticals / Biologics Manufacturing / Regulatory Affairs
Required skills
Project management, CMC documentation authoring, biologics manufacturing principles, analytical methods, control strategies, regulatory compliance, stakeholder management, AI tool evaluation
Preferred skills
Experience with monoclonal antibodies and antibody-drug conjugates, AI tool application in scientific workflows, Lean capability, risk management
Technologies
AI-enabled authoring tools, ISPR development tools
Responsibilities
Author and deliver approved CMC contributions for marketing applications and post-approval submissions; Generate and coordinate responses to Health Authority questions; Ensure technical accuracy and regulatory compliance of human and AI-generated content; Apply project management to evolving submission requirements; Maintain knowledge of biologics development and manufacturing processes; Collaborate across GTO, Regulatory Affairs, Quality, and external partners; Contribute to process optimization and capability building.
Seniority
Manager, hands-on IC with project leadership