API Manufacturing Manager

Role: Oversight of API commercial contract manufacturing organizations (CMOs) within Neurocrine Biosciences' supply chain, ensuring quality, delivery, and operational excellence for marketed products. Responsibilities: manage CMO performance, lead technical reviews, oversee scheduling, production, quality control, risk mitigation, and supply chain logistics; develop policies for operational oversight and supplier management; support validation, procurement, and compliance activities with cGMP standards; collaborate with cross-functional teams including Quality, Regulatory, and Development. Requirements: BS/BA in Engineering, Science, or related field with 6+ years (or Master's with 4+ years) experience in CMC manufacturing, process development, or packaging within a regulated pharmaceutical environment. Expertise in API CMC, tech transfer, validation, and small/large molecule manufacturing required. Strong project management, risk assessment, and process improvement skills (e.g., Lean/Six Sigma). Knowledge of US/EU regulatory standards and experience with commercial-scale production essential. Preferred skills include excellent communication, collaboration, and stakeholder management abilities. High-Value: API CMC manufacturing, solid oral dosage focus, cGMP compliance, experience with marketed products, cross-functional collaboration, risk management, and supplier oversight. WorkSetup: Not specified; likely hybrid or onsite based on typical manufacturing oversight roles.