Manager, Bioanalytical Regulatory

Neurocrine Biosciences seeks a Manager of Bioanalytical Regulatory to oversee contract research organization bioanalytical functions and lead method development and validation efforts across preclinical and clinical programs. The role requires strategic oversight of DMPK bioanalytical initiatives while serving as a subject matter expert and mentor to junior staff.

Responsibilities

• Oversee bioanalytical CRO activities including method transfer, development, validation, and data quality
• Manage contracts and coordinate with CROs on pharmacokinetics, toxicokinetics, immunogenicity, and biomarker analysis
• Conduct CRO evaluation, review standard operating procedures, and perform site visits and inspections
• Provide technical monitoring of bioanalytical method development, validation, and sample analysis
• Lead and mentor junior team members on preclinical and clinical bioanalytical projects

Requirements

• BS/BA in chemistry, biology, or related field with 8+ years hands-on bioanalytical experience
• Master's degree with 6+ years relevant experience, or PhD with 3+ years experience
• Expertise in LC-MS/MS, LC/UV, enzyme-based and immune-based assays
• Demonstrated competency in GLP method development, validation, and regulated bioanalysis
• Strong background as bioanalytical subject matter expert on discovery teams
• Excellent written and verbal communication skills
• Knowledge of regulatory guidance, GLP bioanalysis principles, and CRO management