Drug Product Manufacturing Manager

Neurocrine Biosciences seeks a Drug Product Manufacturing Manager to oversee contract manufacturing relationships and operations within the supply chain. The role involves managing CMO performance, coordinating cross-functional teams, ensuring regulatory compliance, and optimizing manufacturing outcomes for commercial drug products.

Responsibilities

• Oversee CMO relationships, contracts, and activities as primary point of contact for supply chain management
• Lead cross-functional collaboration to determine manufacturing strategies, identify risks, and execute plans
• Manage CMO operational performance including delivery, metrics, budgeting, and risk mitigation
• Review and approve production documents including batch records, protocols, and technical reports
• Partner with Quality Assurance to ensure cGMP compliance and adherence to Neurocrine SOPs

Requirements

• BS/BA in Engineering, Science, or related field plus 6+ years pharmaceutical CMC manufacturing experience
• OR Master's degree in Engineering, Science, or related field plus 4+ years relevant experience
• Direct experience manufacturing or packaging marketed solid oral dosage products
• Expertise in drug product CMC including tech transfer, validation, and commercial scale production
• Knowledge of cGMP, US/EU regulatory requirements, and quality standards
• Proficiency with risk management tools (FMEA) and process improvement methodologies (Lean, Six Sigma)
• Strong project planning, contract management, budgeting, and cost control capabilities