Principal Scientist, Pharmaceutical Development

Neurocrine Biosciences • San Diego, CA

2d • $156,900 - $214,000

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 on project teams from early discovery through 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 advance safe, effective, 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 provide recommendations 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 position primarily supports pre-FIH activities and includes scientific mentorship, cross-functional leadership, evaluation of emerging technologies, and authorship and review of scientific and regulatory documents.

Requirements

• BS/BA in Chemistry, Biochemistry, Chemical Engineering, or a related field and 8+ years of pharmaceutical industry experience in a chemistry, analytical, or characterization laboratory setting; or MS/MA in one of these fields and 6+ years of similar experience; or PhD in one of these fields and 4+ years of similar experience, which may include postdoctoral experience.
• Technical expertise in analytical method development and preformulation sciences.
• Expertise in fit-for-purpose method development and phase-appropriate method qualification and validation to determine solubility, stability, and other pharmaceutically relevant properties of novel therapeutics, including small molecules, peptides, and other biologic modalities.
• Experience with pharmaceutical dosage forms, including parenteral, oral solutions and suspensions, SDD, HME, and SEDDS, to design developability studies and identify potential development risks.
• Ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
• Demonstrated 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 expert-level knowledge in one scientific discipline.
• Extensive knowledge of characterization instrumentation and techniques, including the ability to evaluate and implement emerging technologies.
• Analytical thinking, problem-solving ability, and adaptability to changing priorities and deadlines.
• Ability to apply external scientific literature, competitive intelligence, and emerging technologies 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.
• Proven ability to lead multiple teams and influence cross-functional and matrixed organizations, providing technical leadership to junior scientists and indirect teams.
• Strong leadership capability, strategic thinking, and organizational awareness.
• Excellent computer proficiency, data analysis capability, communication, analytical thinking, and complex problem-solving skills.
• Ability to assess broader organizational impacts 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 and studies, including HPLC-UV, LC-MS, MS-MS, and SEC-HPLC, to support early pharmaceutical development.
• 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 for 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.

Benefits

• Annual bonus with a target of 30% of earned base salary.
• Eligibility to participate in an equity-based long-term incentive program.
• Retirement savings plan with company match.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal