Senior Scientist, Analytical Development (Small Molecule)
Neurocrine Biosciences
June 29, 2026
On-site
San Diego, CA
Clinical Research and Development
About The Role
- The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase.
- Independently manages analytical activities for assigned programs including development, execution, validation, transfer, and troubleshooting of methods used to control raw materials, in-process, intermediates, and final products; oversees work performed at external CROs/CDMOs.
- Works cross-functionally with CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions; contributes to control strategy development.
Your Contributions (include, But Are Not Limited To)
- Develop/optimize phase-appropriate analytical methods for starting materials, intermediates, and drug substances (e.g., HPLC, GC, MS, IC, FTIR, UV, NMR, KF).
- Verify/validate analytical methods in cGMP compliance.
- Characterize small molecules; conduct stability and forced degradation studies; support impurity identification.
- Lead analytical development; provide scientific leadership for quality investigations (OOS/OOT, deviations, root cause, CAPAs).
- Maintain laboratory documentation; communicate results and risks via technical reports/presentations.
- Ensure safe laboratory practices; create novel concepts/techniques; contribute to policies/strategies.
Requirements
- BS/BA in Chemistry/Biochemistry (or related) + 5+ years, OR MS/MA + 3+ years, OR PhD with relevant experience.
- Strong expertise in testing, method development/verification/validation, characterization, and stability support for small molecules.
- Proficiency with HPLC/UPLC/GC/KF/IC/IR/MS/Spectroscopy/UV/XRPD.
- Understanding of pharmaceutical development and phase-appropriate control strategies; cGMP knowledge for drug substance/product.
- Knowledge of FDA/EMA/WHO/ICH regulatory requirements.
Benefits
- Annual base salary: $110,800.00–$151,000.00; annual bonus (target 20%) and eligibility for equity long-term incentive.
- Retirement savings plan (company match), paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
- The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase.
- Independently manages analytical activities for assigned programs including development, execution, validation, transfer, and troubleshooting of methods used to control raw materials, in-process, intermediates, and final products; oversees work performed at external CROs/CDMOs.
- Works cross-functionally with CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions; contributes to control strategy development.
Your Contributions (include, But Are Not Limited To)
- Develop/optimize phase-appropriate analytical methods for starting materials, intermediates, and drug substances (e.g., HPLC, GC, MS, IC, FTIR, UV, NMR, KF).
- Verify/validate analytical methods in cGMP compliance.
- Characterize small molecules; conduct stability and forced degradation studies; support impurity identification.
- Lead analytical development; provide scientific leadership for quality investigations (OOS/OOT, deviations, root cause, CAPAs).
- Maintain laboratory documentation; communicate results and risks via technical reports/presentations.
- Ensure safe laboratory practices; create novel concepts/techniques; contribute to policies/strategies.
Requirements
- BS/BA in Chemistry/Biochemistry (or related) + 5+ years, OR MS/MA + 3+ years, OR PhD with relevant experience.
- Strong expertise in testing, method development/verification/validation, characterization, and stability support for small molecules.
- Proficiency with HPLC/UPLC/GC/KF/IC/IR/MS/Spectroscopy/UV/XRPD.
- Understanding of pharmaceutical development and phase-appropriate control strategies; cGMP knowledge for drug substance/product.
- Knowledge of FDA/EMA/WHO/ICH regulatory requirements.
Benefits
- Annual base salary: $110,800.00–$151,000.00; annual bonus (target 20%) and eligibility for equity long-term incentive.
- Retirement savings plan (company match), paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).