Bioanalytical Regulatory Lead

Neurocrine Biosciences

San Diego (CA)

On-site

USD 131,000 - 179,000

Full time

6 days ago

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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.