API Manufacturing & CMO Partnerships Lead

Neurocrine Biosciences; San Diego (CA); On-site; USD 120,000 - 164,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Personal days

Medical leave

Health benefits

Job summary

Neurocrine Biosciences seeks a senior professional to oversee API commercial contract manufacturing with CMOs. You will lead technical reviews, negotiate supplier terms, and ensure cGMP compliance across production, quality, and regulatory functions.

You will drive risk mitigation, cost controls, and on-time delivery while aligning with strategic objectives. The role requires strong collaboration with QA, Regulatory, and Development teams, plus experience in budgeting and RFQ/RFP processes.

Qualifications

• BS/BA in Engineering, Science or related field, plus 6+ years in CMC Manufacturing or related pharmaceutical ops.
• Experience with solid oral dosage manufacturing or packaging operations.
• Direct experience with manufacture/packaging of marketed products in a cGMP env.
• Knowledge of regulatory and quality requirements US/EU for pharma.

Responsibilities

• Lead API commercial manufacturing decisions with CMOs and internal teams.
• Interact with senior management on manufacturing matters.
• Manage priorities across Neurocrine commercial activities at CMOs.
• Ensure schedules, plans, and performance requirements are met.
• Oversee supplier risk, cost, quality, and delivery metrics.

Skills

CMC Manufacturing

Cross-functional collaboration

Project planning

Regulatory knowledge

Risk management

Negotiation skills

Education

BS/BA in Engineering or Science

MS in Engineering/Science (optional)

Tools

cGMP systems

Quality documents systems

ERP/production software

Job description

Neurocrine Biosciences seeks a senior professional to oversee API commercial contract manufacturing with CMOs. You will lead technical reviews, negotiate supplier terms, and ensure cGMP compliance across production, quality, and regulatory functions.

You will drive risk mitigation, cost controls, and on-time delivery while aligning with strategic objectives. The role requires strong collaboration with QA, Regulatory, and Development teams, plus experience in budgeting and RFQ/RFP processes.