Senior Scientist, Analytical Development (Small Molecule)
Neurocrine Biosciences
August 11, 2026
On-site
San Diego, CA
Operations
About the Role
Senior Scientist, Analytical Development — analytical development activities for small molecule drug substances from preclinical through commercial phase. Laboratory-focused; manages development, execution, validation, transfer and troubleshooting of methods to control raw materials, in-process, intermediates and final products; oversees external CRO/CDMO analytical work. Conducts work in compliance with cGMP, safety, and regulatory requirements. Works cross-functionally (CMC, Technical Ops, Quality, Regulatory, Manufacturing) to support product development, manufacturing readiness, and regulatory submissions; contributes to control strategy.
Your Contributions
- Develop/optimize phase-appropriate analytical methods (e.g., HPLC, GC, MS, IC, FTIR, UV, NMR, KF)
- Verify/validate methods in cGMP compliance
- Characterize small molecules; support stability and forced degradation; support impurity ID
- Lead analytical development and contribute to control strategy
- Support quality investigations (OOS/OOT, deviations, root cause, CAPAs)
- Maintain compliant lab documentation; communicate results via reports/presentations
- Ensure safe lab practices; support off-site transfers and manufacturing; train others
Requirements
- BS/BA + 5+ years (or MS/MA + 3+, or PhD with relevant experience)
- Expertise in method development, verification/validation, characterization, and stability for small molecules
- Proficiency with HPLC/UPLC, GC, KF, IC, IR, MS, spectroscopy, UV, XRPD
- Knowledge of cGMP and FDA/EMA/WHO/ICH regulatory requirements
Benefits (as stated)
Base salary $110,800–$151,000; annual bonus (target 20%); retirement match; paid vacation/holidays/personal days; caregiver/parental & medical leave; medical/dental/vision.
Senior Scientist, Analytical Development — analytical development activities for small molecule drug substances from preclinical through commercial phase. Laboratory-focused; manages development, execution, validation, transfer and troubleshooting of methods to control raw materials, in-process, intermediates and final products; oversees external CRO/CDMO analytical work. Conducts work in compliance with cGMP, safety, and regulatory requirements. Works cross-functionally (CMC, Technical Ops, Quality, Regulatory, Manufacturing) to support product development, manufacturing readiness, and regulatory submissions; contributes to control strategy.
Your Contributions
- Develop/optimize phase-appropriate analytical methods (e.g., HPLC, GC, MS, IC, FTIR, UV, NMR, KF)
- Verify/validate methods in cGMP compliance
- Characterize small molecules; support stability and forced degradation; support impurity ID
- Lead analytical development and contribute to control strategy
- Support quality investigations (OOS/OOT, deviations, root cause, CAPAs)
- Maintain compliant lab documentation; communicate results via reports/presentations
- Ensure safe lab practices; support off-site transfers and manufacturing; train others
Requirements
- BS/BA + 5+ years (or MS/MA + 3+, or PhD with relevant experience)
- Expertise in method development, verification/validation, characterization, and stability for small molecules
- Proficiency with HPLC/UPLC, GC, KF, IC, IR, MS, spectroscopy, UV, XRPD
- Knowledge of cGMP and FDA/EMA/WHO/ICH regulatory requirements
Benefits (as stated)
Base salary $110,800–$151,000; annual bonus (target 20%); retirement match; paid vacation/holidays/personal days; caregiver/parental & medical leave; medical/dental/vision.