Principal Scientist, Pharmaceutical Development
Neurocrine Biosciences
Summary
Neurocrine Biosciences is seeking an experienced Principal Scientist, Preformulation & Pharmaceutical Development, to provide scientific expertise, technical oversight, and strategic guidance across multiple drug development programs. Serve as a senior technical leader within Pharmaceutical Development, representing Technical Operations in project teams across the product lifecycle from early discovery into clinical development.
Job description
About the Role
Neurocrine Biosciences is seeking an experienced Principal Scientist, Preformulation & Pharmaceutical Development, to provide scientific expertise, technical oversight, and strategic guidance across multiple drug development programs. Serve as a senior technical leader within Pharmaceutical Development, representing Technical Operations in project teams across the product lifecycle from early discovery into clinical development.
The successful candidate will collaborate with Discovery, Preclinical and Clinical Pharmacology, Pharmaceutical Development, Analytical Development, and other Technical Operations functions to anticipate downstream development challenges and support the advancement of safe, effective, and developable drug candidates.
Your Contributions
- Serve as a scientific subject matter expert in preformulation and pharmaceutical developability, providing technical guidance and strategic recommendations across multiple drug development programs, primarily supporting pre-FIH activities
- Design and develop fit-for-purpose phase-appropriate analytical methods (HPLC-UV, LC-MS, MS-MS, SEC-HPLC, etc.) studies in support of early pharmaceutical development activities
- Design, execute, and oversee phase-appropriate preformulation and developability studies, including physicochemical characterization, solubility, stability, formulation feasibility, and analytical method development
- Apply broad pharmaceutical development experience to identify developability risks, evaluate experimental findings, and recommend strategies that support candidate selection, formulation development, and CMC decision-making
- Provide independent scientific review of experimental designs, analytical data, electronic laboratory notebooks, technical reports, developability assessments, and regulatory documentation to ensure scientific rigor and quality
- Serve as a technical mentor to scientists, providing guidance on experimental approaches, troubleshooting, data interpretation, scientific writing, and development best practices
- Collaborate with multidisciplinary R&D and Technical Operations teams to communicate scientific findings, anticipate downstream development challenges, and influence program strategy and advancement
- Evaluate and implement innovative analytical technologies, scientific approaches, and process improvements to enhance preformulation capabilities and development efficiency
- Author and review technical reports, scientific presentations, and relevant regulatory submissions while supporting knowledge sharing and scientific excellence across the organization
Requirements
- BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 8+ years of pharmaceutical industry experience in a chemistry, analytical, or characterization laboratory setting
- OR MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 6+ years of similar experience
- OR PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience; may include postdoc experience
- Must have technical expertise in analytical method development and preformulation sciences
- Expertise with fit-for-purpose method development and phase appropriate method qualification/validation to determine solubility, stability, and other pharmaceutically relevant properties of novel therapeutics (including small molecules, peptides, and other biologic modalities)
- Familiarity with a variety of pharmaceutical dosage forms (parenteral, oral solutions/suspensions, SDD, HME, SEDDS, etc.)
- Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions
- Strong knowledge and expertise in HPLC (SEC, UV, MS, IEX, etc), solubility analysis, pKa determination, Log P/D, and other preformulation studies
- Working knowledge of DSC, TGA, PXRD, NMR, Particle-Size Analysis, GVS, PLM, and SEM
- Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
- Strong knowledge of scientific principles, methods and techniques
- Extensive knowledge of characterization instrumentation and techniques
- Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Proven ability to lead multiple teams and influence cross-functional and matrixed organizations
- Excellent computer proficiency and data analysis capability
- Exceptional communication, analytical thinking, and complex problem-solving skills
- Excellent project management skills, including long-range planning and execution
- Strong cross-functional understanding related to molecule selection and drug development is strongly preferred
- Technical expertise in LC-MS is strongly preferred
- Working knowledge of Agilent OpenLab software is a plus
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical, Dental & Vision
- Prescription Drug Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.