Senior Bioanalytical Regulatory Lead

Socket.dev; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Benefits offered by this job

Annual bonus

Equity long-term incentives

Health benefits

Job summary

Neurocrine Biosciences is seeking a senior bioanalytical professional to oversee CROs, develop and validate GLP-compliant methods, and mentor junior staff. You will manage PK/TK analyses, coordinate regulatory-ready studies, and contribute to IND/BLA submissions.

Ideal candidates have extensive LC-MS/MS and high-resolution mass spectrometry experience, strong communication skills, and a track record in regulated bioanalysis within CRO partnerships.

Qualifications

• BS/BA in chemistry or biology with 8+ years of hands-on experience in automation and bioanalytical methods.
• MS in chemistry/biology with 6+ years of relevant bioanalysis experience.
• PhD with 3+ years of related work and postdoc experience is acceptable.
• Expertise as a bioanalytical SME on discovery teams.
• Strong experience with GLP method development and validation.
• Proficiency in PK/TK analysis and regulatory bioanalysis guidance.

Responsibilities

• Oversee bioanalytical CROs to ensure GLP/GCP data quality and timely reports.
• Coordinate PK/TK, dose formulation analysis, immunogenicity, and biomarker work with CROs.
• Prepare and review regulatory documents and study protocols for INDs/BLAs.
• Evaluate CROs, review SOPs, and conduct site visits and inspections.
• Monitor method development, validation, and data transfer between CROs.
• Lead strategic project goals and mentor junior team members.
• Interact with outsourcing partners to ensure contractual standards within budget.
• Support regulatory submissions with expert contributions.

Skills

Automation

LC-MS/MS

LC-UV

Enzyme-based assays

Immunoassays

PK/TK analysis

Education

BS/BA in chemistry/biology +8 years

MS in chemistry/biology +6 years

PhD in chemistry/biology +3 years

Tools

High resolution mass spectrometry

ToF / Orbitrap / FT-ICR

Job description

Neurocrine Biosciences is seeking a senior bioanalytical professional to oversee CROs, develop and validate GLP-compliant methods, and mentor junior staff. You will manage PK/TK analyses, coordinate regulatory-ready studies, and contribute to IND/BLA submissions.

Ideal candidates have extensive LC-MS/MS and high-resolution mass spectrometry experience, strong communication skills, and a track record in regulated bioanalysis within CRO partnerships.