Scientist II, Pharmaceutical Development

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 111,000 - 151,000; Full time

Job summary

Neurocrine Biosciences, Inc. in San Diego seeks an experienced formulation scientist to represent Product Development on CMC project teams from discovery to commercial launch, providing formulation and analytical expertise to support preclinical and clinical programs.

You will design preformulation and formulation studies, lead process development and scale-up, apply QbD and DOE, and ensure regulatory readiness through cGMP-compliant documentation and cross-functional collaboration.

Qualifications

• 4+ years in pharmaceutical industry development or manufacturing.
• Experience in preclinical/clinical and regulatory environments is preferred.
• Hands-on experience with formulation/process development and scale-up.

Responsibilities

• Lead preformulation and formulation development studies to enable product progression.
• Plan and execute DOE-backed studies aligned with QbD for process optimization.
• Coordinate tech transfer and scale-up activities from development to manufacturing.
• Prepare regulatory documentation and support IND/NDA submissions.

Skills

Formulation development

DOE (Design of Experiments)

Quality by Design (QbD)

Cross-functional collaboration

Regulatory submissions support

cGMP knowledge

Analytical method understanding

Education

BS/BA in Chemistry, Biochemistry, Chemical Engineering, or related field

MS/MA in Chemistry, Biochemistry, Chemical Engineering, or related field

PhD in Chemistry, Biochemistry, Chemical Engineering, or related field

Tools

Statistical analysis software

DOE software

Job description

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:Represent Product Development on CMC project teams across all stages of development, from early discovery through commercial launch. Provide formulation and analytical expertise to support multiple preclinical and clinical programs. Design and execute preformulation and formulation development studies to enable product advancement, delivering phase-appropriate, safe, and therapeutically effective dosage forms that support regulatory progression and commercialization. Lead the development and optimization of manufacturing processes for a variety of pharmaceutical compounds, applying a deep understanding of material properties, operating parameters, and their impact on critical quality attributes to ensure robust performance throughout development, scale-up, and commercial readiness._Your Contributions (include, but are not limited to):Collaborate cross-functionally with Research/Discovery, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, Supply Chain, and external CDMO partners to advance programs from early discovery through commercial launch, ensuring effective communication and alignment across departments and organizationsApply first principles of formulation and process science to design and execute preformulation and formulation development studies to deliver phase-appropriate dosage forms aligned with target product profilesPlan and execute studies using Quality by Design (QbD) principles, including Design of Experiments (DOE), to optimize formulations and manufacturing processes across development stagesPrepare, evaluate, and optimize formulations for preclinical and clinical use and determine downstream manufacturability risksLead pilot-scale and commercial process scale-up activities in support of scale-up and technical transfer activitiesRepresent the company during on-site CDMO manufacturing campaigns (“person-in-plant”), ensuring adherence to partner SOPs and effective technical communicationResearch, evaluate, source, procure, install, qualify, operate, and maintain instrumentation and emerging formulation technologies to support preformulation, material science, and process development activitiesPrepare, review, and maintain pharmaceutical development documentation including laboratory notebooks (per SOP), protocols, reports, specifications, batch records, and CMC regulatory submissions, ensuring scientific integrity and compliance with cGMP and global regulatory requirementsMaintain organized documentation repositories for formulation and material characterization data, development reports, and process knowledge to support knowledge management and regulatory readinessLead or participate in periodic project team meetings, clearly communicating progress, risks, timelines, and resource needs to stakeholders and leadershipMay mentor or train junior scientists as appropriatePerform other duties as assignedRequirements:BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of pharmaceutical industry experience, including experience in a chemistry, analytical, or characterization laboratory setting ORMS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 2+ years of similar experience noted above ORPhD in Chemistry, Biochemistry, Chemical Engineering, or related fieldandsome relevant experience; may include postdoc experienceStrong working knowledge of cGMP requirements across early- and late-stage drug product development and manufacturing, with a demonstrated quality and compliance mindsetHands-on experience with pharmaceutical manufacturing processes developmentDemonstrated cross-functional understanding of drug development from discovery through commercialization, including CMC strategy and lifecycle managementExperience supporting or leading technology transfer activities to pilot, clinical, or commercial manufacturing sites and/or CDMOsStrong working knowledge of Quality by Design (QbD) principles and application of statistical analysis software and risk assessment tools across the product lifecycleStrong familiarity with analytical method development, validation, stability programs, and characterization techniquesExperience contributing to regulatory submissions (e.g., IND, NDA, MAA) and authoring or reviewing drug product sections with minimal supervisionWorking knowledge of ICH, FDA, and EMA CMC guidance relevant to drug product development and commercializationExperience contributing to project planning, resource forecasting, and risk management activitiesDemonstrates strong understanding of project, functional, and CMC program goals; aligns scientific activities with broader development and regulatory strategyConsistently identifies anomalous or inconsistent data, determines root cause, and implements scientifically sound solutions with minimal oversightRecognized technical expert within at least one scientific discipline; applies deep scientific knowledge to solve complex formulation and process challengesStrong command of scientific principles, methods, and techniques, with ability to translate theory into practical development solutionsDemonstrated proficiency with a broad range of laboratory, analytical, and pharmaceutical manufacturing equipment; able to troubleshoot technical and operational issues independentlyStrong analytical thinking and creative problem-solving skills in a cross-functional, matrix environmentExcellent written and verbal communication skills, including preparation of technical reports and delivery of scientific presentations to internal and external stakeholdersEffective project management skills with the ability to manage multiple programs, prioritize competing deadlines, and drive deliverables to completionDetail-oriented while maintaining awareness of broader scientific, regulatory, and commercial implicationsBuilds strong cross-functional relationships and influences stakeholders through sound scientific rationale and data-driven argumentsDemonstrates accountability for own work and project outcomes; may mentor junior scientists and provide technical guidance#LI-LS1Neurocrine 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 $110,800.00-$151,000.00. 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 20% 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.