Neurocrine Biosciences seeks an API Manufacturing Manager in San Diego to oversee contract manufacturing relationships and commercial production activities. The role manages supplier performance, ensures regulatory compliance, and coordinates cross-functional activities to maintain on-time delivery and quality standards.
Responsibilities
- Lead cross-functional teams and contract manufacturers to plan commercial API manufacturing and mitigate key risks
- Manage CMO operational activities including schedules, timelines, costs, and ensure on-time product delivery
- Review and approve pre- and post-production documents including batch records, protocols, and technical reports
- Partner with Quality Assurance to ensure CMO compliance with cGMP guidelines and company SOPs
- Develop supplier management processes, scorecards, and support RFQ/RFP preparation and supply agreement negotiation
Requirements
- BS/BA in Engineering, Science, or related field with 6+ years pharmaceutical CMC manufacturing or packaging experience; or Master's degree with 4+ years equivalent experience
- Direct experience manufacturing or packaging marketed solid oral dosage products, emphasizing drug substance or packaging operations
- Expertise with API CMC including tech transfer, validation, and commercial-scale production
- Knowledge of cGMP-regulated environments and US/EU regulatory, quality, and standards requirements
- Proficiency with risk management tools (FMEA) and process improvement methodologies (Lean, Six Sigma, CPV)
- Strong contract, budgeting, project planning, and cost control understanding
- Excellent analytical, problem-solving, written, oral, and interpersonal communication skills
API Manufacturing Manager in san diego at Unknown Company
This position is listed as contract and onsite.