Senior Scientist, CMC Downstream Process Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Job summary

Neurocrine Biosciences seeks a scientific leader for assigned development assets, shaping strategy from early development through commercialization and ensuring regulatory defensibility. You will guide technical direction, lead risk assessments, and mentor scientists while coordinating cross-functional teams across QA, manufacturing, and regulatory.

This role emphasizes process development, scale-up, tech transfer, and making data-driven decisions to improve product quality and manufacturing

Qualifications

• Advanced degree in chemistry or engineering, with substantial pharma process development experience.
• Experience leading multiple teams and cross-functional drug development.
• Strong communication and analytical skills.
• Knowledge of cGMP and regulatory requirements.
• Experience with scale-up and technology transfer.

Responsibilities

• Apply advanced principles to solve complex process development challenges.
• Lead process scale-up and technology transfer initiatives.
• Plan and manage scientific activities in cross-functional teams.
• Mentor scientists and manage asset-level deliverables.
• Provide scientific leadership for regulatory documentation.
• Manage contract manufacturing activities.
• Identify and resolve process challenges using data-driven approaches.
• Maintain safety and productivity in lab operations.

Skills

Scientific leadership

Cross-functional collaboration

Risk assessment

Data-driven decision making

Project management

Education

PhD in chemistry or related

MS in chemistry or related

BS in chemistry or related

Tools

Laboratory instrumentation

Process validation tools

Job description

Neurocrine Biosciences seeks a scientific leader for assigned development assets, shaping strategy from early development through commercialization and ensuring regulatory defensibility. You will guide technical direction, lead risk assessments, and mentor scientists while coordinating cross-functional teams across QA, manufacturing, and regulatory.

This role emphasizes process development, scale-up, tech transfer, and making data-driven decisions to improve product quality and manufacturing