Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
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.
The Principal Scientist will apply 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 across process development, material characterization, and analytical strategies to enable phase-appropriate development, manage developability risks, and support intellectual property and commercial objectives.
_
Your Contributions (include, but are not limited to):
- 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
- Other duties as assigned
Requirements:
- BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 8+ years of pharmaceutical industry experience, specifically 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 noted above OR
- PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above; may include postdoc experience
- Strong cross-functional understanding related to molecule selection and drug development is strongly preferredMust have technical expertise in analytical method development and preformulation sciences
- Technical expertise in LC-MS is strongly preferred
- Working knowledge of Agilent OpenLab software is a plus
- 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.) to design appropriate developability studies and identify potential development risks
- Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
- Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions
- Strong knowledge and expertise of the following instrumentation and techniques is required; HPLC (SEC, UV, MS, IEX, etc), solubility analysis, pKa determination, Log P/D, and other preformulation studies
- A working knowledge of the following is required; 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; evaluates and implements emerging technologies to enhance development capabilities
- Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Assimilates external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs
- Understands related functional areas and interdependencies across drug development, manufacturing, and regulatory domains
- Demonstrates 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; provides technical leadership to junior scientists and indirect teams
- Exhibits strong leadership capability, strategic thinking, and organizational awareness
- Excellent computer proficiency and data analysis capability
- Exceptional communication, analytical thinking, and complex problem-solving skills
- Sees the broader organizational impact of decisions across programs, departments, and portfolios
- Effectively manages multiple high-priority programs simultaneously with accuracy, efficiency, and accountability
- Excellent project management skills, including long-range planning and execution
- Maintains broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplines
- Holds self and team accountable for results; sets clear objectives and articulates measurable outcomes
#LI-DM1
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
_
The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.