Bioanalytical Regulatory Lead

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

Job summary

Neurocrine Biosciences in San Diego seeks a Bioanalytical Subject Matter Expert to oversee CROs, ensuring GLP/GCP compliant bioanalytical method development, validation and data quality across PK/TK analyses. You will mentor junior scientists, guide project teams, and contribute to regulatory submissions while coordinating with discovery and clinical groups.

Experience with LC-MS/MS, high-resolution MS and regulatory bioanalysis is required; strong leadership and communication skills are

Qualifications

• BS/BA in chemistry/biology with 8+ years hands-on bioanalytical experience or MS with 6+ years or PhD with 3+ years.
• Expertise as a bioanalytical SME on discovery teams.
• Extensive hands-on experience with automation, LC-MS/MS, high-resolution MS, and PK/TK analyses.
• Regulatory GLP method development and validation experience.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee regulated (GLP/GCP) bioanalytical methods transfer, development and validation at CROs.
• Initiate and manage CRO contracts and coordinate PK, TK, dose formulation analysis and biomarkers.
• Contribute to study protocols, regulatory documents and interactions for INDs, BLAs, RFMs and IRs.
• Conduct CRO evaluation, review SOPs, and perform site visits/inspections.
• Mentor and supervise junior team members; lead multiple teams.

Skills

LC-MS/MS

Bioanalytical methods

GLP knowledge

Project leadership

Mentorship

Education

BS/BA in chemistry/biology

MS/PhD in chemistry/biology

Tools

Automation

High-resolution MS

Mass spectrometry

Job description

Neurocrine Biosciences in San Diego seeks a Bioanalytical Subject Matter Expert to oversee CROs, ensuring GLP/GCP compliant bioanalytical method development, validation and data quality across PK/TK analyses. You will mentor junior scientists, guide project teams, and contribute to regulatory submissions while coordinating with discovery and clinical groups.

Experience with LC-MS/MS, high-resolution MS and regulatory bioanalysis is required; strong leadership and communication skills are