Principal Scientist, Pharmaceutical Development

Neurocrine Biosciences•San Diego, CA

About The Position

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. The role serves 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 scientist collaborates with Discovery, Preclinical and Clinical Pharmacology, Pharmaceutical Development, Analytical Development, and other Technical Operations functions to anticipate downstream development challenges and advance safe, effective, and developable drug candidates. The Principal Scientist applies broad pharmaceutical industry experience to develop fit-for-purpose analytical methods, guide preformulation strategies, assess developability risks, critically evaluate scientific data, and recommend approaches that inform candidate selection, formulation development, and CMC decision-making. The work spans process development, material characterization, and analytical strategies to enable phase-appropriate development, manage developability risks, and support intellectual property and commercial objectives. The role primarily supports pre-FIH activities.

Requirements

A BS/BA in Chemistry, Biochemistry, Chemical Engineering, or a related field and 8 or more years of pharmaceutical industry experience in a chemistry, analytical, or characterization laboratory setting; or an MS/MA in one of these fields and 6 or more years of similar experience; or a PhD in one of these fields and 4 or more years of similar experience. Postdoctoral experience may count.
Technical expertise in analytical method development and preformulation sciences.
Expertise in fit-for-purpose method development and phase-appropriate method qualification or validation to determine solubility, stability, and other pharmaceutically relevant properties of novel therapeutics, including small molecules, peptides, and other biologic modalities.
Knowledge of pharmaceutical dosage forms, including parenteral, oral solutions or suspensions, SDD, HME, and SEDDS, to design developability studies and identify potential development risks.
Ability to recognize anomalous or inconsistent results and interpret experimental outcomes.
Regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions.
Strong knowledge of instrumentation and techniques including 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 scientific principles, methods, and techniques, with expertise in at least one scientific discipline.
Extensive knowledge of characterization instrumentation and techniques, including the ability to evaluate and implement emerging technologies.
Analytical thinking, problem-solving skills, and the ability to adapt to changing priorities and deadlines.
Ability to assimilate external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs.
Understanding of related functional areas and interdependencies across drug development, manufacturing, and regulatory domains.
Advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologies.
Ability to lead multiple teams and influence cross-functional and matrixed organizations, and to provide technical leadership to junior scientists and indirect teams.
Leadership capability, strategic thinking, and organizational awareness.
Excellent computer proficiency and data-analysis capability.
Exceptional communication, analytical thinking, and complex problem-solving skills.
Ability to understand the broader organizational impact of decisions across programs, departments, and portfolios.
Ability to manage multiple high-priority programs simultaneously with accuracy, efficiency, and accountability.
Excellent project management skills, including long-range planning and execution.
Ability to hold self and team accountable for results, set clear objectives, and articulate measurable outcomes.

Nice To Haves

Strong cross-functional understanding related to molecule selection and drug development.
Technical expertise in LC-MS.
Working knowledge of Agilent OpenLab software.

Responsibilities

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, including HPLC-UV, LC-MS, MS-MS, and SEC-HPLC, for 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.
Identify developability risks, evaluate experimental findings, and recommend strategies supporting candidate selection, formulation development, and CMC decision-making.
Independently review experimental designs, analytical data, electronic laboratory notebooks, technical reports, developability assessments, and regulatory documentation to ensure scientific rigor and quality.
Mentor scientists on experimental approaches, troubleshooting, data interpretation, scientific writing, and development best practices.
Collaborate with multidisciplinary R&D and Technical Operations teams to communicate 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, and support organizational knowledge sharing and scientific excellence.
Perform other duties as assigned.