Scientist II, Analytical Development

Neurocrine Biosciences seeks a Scientist II in Analytical Development to lead analytical chemistry activities for small molecule drug substances from preclinical through commercial phases. The role involves method development, validation, and troubleshooting in compliance with cGMP and regulatory standards, with cross-functional collaboration across CMC, manufacturing, and external partners.

Responsibilities

• Design, plan, and execute analytical development activities supporting preclinical through commercial drug substance and product processes
• Develop, validate, and troubleshoot analytical methods for raw materials, in-process controls, intermediates, and final products
• Provide project management and oversight of analytical work at external CROs and CDMOs
• Represent analytical chemistry on cross-functional teams and contribute to CMC regulatory documentation
• Supervise laboratory personnel, ensure cGMP compliance, and provide professional development guidance

Requirements

• Bachelor's degree in chemistry or related field with 4 years pharmaceutical analytical chemistry experience
• Master's degree in chemistry or related field with 2 years pharmaceutical analytical chemistry experience
• PhD in chemistry or related field with some relevant experience
• Hands-on experience in pharmaceutical analysis and methods development/validation
• Knowledge of regulatory requirements, NDA preparation, cGMP, and quality assurance practices
• Strong project management, communication, and problem-solving skills
• Proficiency with laboratory equipment and scientific instrumentation