API Manufacturing Manager

Neurocrine Biosciences · San Diego, CA

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IT & SoftwareFull-time$120k–$164kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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