Associate Scientific Director, Analytical Development
Neurocrine Biosciences
June 24, 2026
On-site
San Diego, CA
Operations
About The Role
- Serve as a subject matter expert and analytical liaison for research and early-stage development, focused on mass spectrometry characterization of antibodies, conjugates, and other large molecules.
- Evaluate developability via structure elucidation, chemical stability assessments, and forced degradation; accumulate product/process understanding to guide lead optimization, process development, and formulation.
- Lead Analytical Development and oversee analytical activities for drug substance/drug product (preclinical through commercial): method development, validation/qualification, specification establishment, and control strategy development.
- Support biomarker discovery (proteomics; targeted quantification) and ensure compliance with GxP, safety, and regulatory requirements.
- Contribute to material/product analysis across development stages; supervise/coaching of junior scientists.
Your Contributions
- Define CQAs/TPP-aligned developability criteria; lead cross-functional analytical alignment.
- Lead analytical methods development/qualification in cGMP settings; maintain accountability for analytical deliverables and CMC/manufacturing progress.
- Use technologies including LC-MS, capillary electrophoresis, peptide mapping, MS, SDS-PAGE, ELISA, HPLC, and glycoprotein/carbohydrate characterization; direct lab work (internal and vendors).
Requirements
- BS/BA +15+ yrs, or MS/MA +13+ yrs, or PhD +10+ yrs.
- Deep MS-based structure characterization and physicochemical/biophysical analysis; expertise with antibodies/conjugates/peptides and biologics development/formulation.
- Method development/validation/transfer in Analytical Development; cGMP and FDA/EMA/WHO/ICH regulatory knowledge; leadership/mentoring and strong communication/project management.
Compensation & Benefits (if applicable)
- Base salary: $173,600–$237,000; annual bonus target 30%; equity long-term incentive eligibility.
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave; medical/dental/vision coverage.
- Serve as a subject matter expert and analytical liaison for research and early-stage development, focused on mass spectrometry characterization of antibodies, conjugates, and other large molecules.
- Evaluate developability via structure elucidation, chemical stability assessments, and forced degradation; accumulate product/process understanding to guide lead optimization, process development, and formulation.
- Lead Analytical Development and oversee analytical activities for drug substance/drug product (preclinical through commercial): method development, validation/qualification, specification establishment, and control strategy development.
- Support biomarker discovery (proteomics; targeted quantification) and ensure compliance with GxP, safety, and regulatory requirements.
- Contribute to material/product analysis across development stages; supervise/coaching of junior scientists.
Your Contributions
- Define CQAs/TPP-aligned developability criteria; lead cross-functional analytical alignment.
- Lead analytical methods development/qualification in cGMP settings; maintain accountability for analytical deliverables and CMC/manufacturing progress.
- Use technologies including LC-MS, capillary electrophoresis, peptide mapping, MS, SDS-PAGE, ELISA, HPLC, and glycoprotein/carbohydrate characterization; direct lab work (internal and vendors).
Requirements
- BS/BA +15+ yrs, or MS/MA +13+ yrs, or PhD +10+ yrs.
- Deep MS-based structure characterization and physicochemical/biophysical analysis; expertise with antibodies/conjugates/peptides and biologics development/formulation.
- Method development/validation/transfer in Analytical Development; cGMP and FDA/EMA/WHO/ICH regulatory knowledge; leadership/mentoring and strong communication/project management.
Compensation & Benefits (if applicable)
- Base salary: $173,600–$237,000; annual bonus target 30%; equity long-term incentive eligibility.
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave; medical/dental/vision coverage.