API Manufacturing Lead, CMO Partnerships

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurocrine Biosciences seeks a senior professional to oversee API contract manufacturing organizations (CMOs) within the supply chain. You will lead technical discussions, review manufacturing, and ensure contractual commitments are honored.

You will manage cross-functional collaboration, drive performance metrics, and ensure timely planning, scheduling, and quality control across CMOs. A strong background in API CMC and regulatory knowledge is required.

Qualifications

• BS/BA degree in Engineering, Science or related field; 6+ years in pharmaceutical CMC manufacturing or related ops.
• Master's degree adds 4+ years of applicable experience.
• Expertise with API CMC, including tech transfer, validation and commercial scale production.
• Experience in a cGMP-regulated environment with US/EU regulatory standards.

Responsibilities

• Oversees relationships, contracts, and activities with API CMOs in Neurocrine's supply chain.
• Single point of contact for CMO relationships and manufacturing reviews.
• Ensures delivery, budget, risk mitigation, and operational metrics are met.
• Drives schedule adherence, cost control, and process improvements at CMOs.
• Supports RFQs, RFPs, and SOWs related to CMOs and supply agreements.
• Partners with Quality Assurance to ensure cGMP compliance.

Skills

API CMC

Tech transfer

Validation

Commercial scale production

Project planning

Resource management

Education

BS/BA degree in Engineering, Science or related field

Master's degree in Engineering, Science or related field

Job description

Neurocrine Biosciences seeks a senior professional to oversee API contract manufacturing organizations (CMOs) within the supply chain. You will lead technical discussions, review manufacturing, and ensure contractual commitments are honored.

You will manage cross-functional collaboration, drive performance metrics, and ensure timely planning, scheduling, and quality control across CMOs. A strong background in API CMC and regulatory knowledge is required.