Scientist II, CMC Antibody Development, Biologics

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.

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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 organizations

• Apply 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 profiles

• Plan and execute studies using Quality by Design (QbD) principles, including Design of Experiments (DOE), to optimize formulations and manufacturing processes across development stages

• Prepare, evaluate, and optimize formulations for preclinical and clinical use and determine downstream manufacturability risks

• Lead pilot-scale and commercial process scale-up activities in support of scale-up and technical transfer activities

• Represent the company during on-site CDMO manufacturing campaigns (“person-in-plant”), ensuring adherence to partner SOPs and effective technical communication

• Research, evaluate, source, procure, install, qualify, operate, and maintain instrumentation and emerging formulation technologies to support preformulation, material science, and process development activities

• Prepare, 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 requirements

• Maintain organized documentation repositories for formulation and material characterization data, development reports, and process knowledge to support knowledge management and regulatory readiness

• Lead or participate in periodic project team meetings, clearly communicating progress, risks, timelines, and resource needs to stakeholders and leadership

• May mentor or train junior scientists as appropriate

• Perform other duties as assigned

Requirements:

• 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 OR
• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 2+ years of similar experience noted above OR
• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field AND some relevant experience; may include postdoc experience
• Strong working knowledge of cGMP requirements across early- and late-stage drug product development and manufacturing, with a demonstrated quality and compliance mindset
• Hands-on experience with pharmaceutical manufacturing processes development
• Demonstrated cross-functional understanding of drug development from discovery through commercialization, including CMC strategy and lifecycle management
• Experience supporting or leading technology transfer activities to pilot, clinical, or commercial manufacturing sites and/or CDMOs
• Strong working knowledge of Quality by Design (QbD) principles and application of statistical analysis software and risk assessment tools across the product lifecycle
• Strong familiarity with analytical method development, validation, stability programs, and characterization techniques
• Experience contributing to regulatory submissions (e.g., IND, NDA, MAA) and authoring or reviewing drug product sections with minimal supervision
• Working knowledge of ICH, FDA, and EMA CMC guidance relevant to drug product development and commercialization
• Experience contributing to project planning, resource forecasting, and risk management activities
• Demonstrates strong understanding of project, functional, and CMC program goals; aligns scientific activities with broader development and regulatory strategy
• Consistently identifies anomalous or inconsistent data, determines root cause, and implements scientifically sound solutions with minimal oversight
• Recognized technical expert within at least one scientific discipline; applies deep scientific knowledge to solve complex formulation and process challenges
• Strong command of scientific principles, methods, and techniques, with ability to translate theory into practical development solutions
• Demonstrated proficiency with a broad range of laboratory, analytical, and pharmaceutical manufacturing equipment; able to troubleshoot technical and operational issues independently
• Strong analytical thinking and creative problem-solving skills in a cross-functional, matrix environment
• Excellent written and verbal communication skills, including preparation of technical reports and delivery of scientific presentations to internal and external stakeholders
• Effective project management skills with the ability to manage multiple programs, prioritize competing deadlines, and drive deliverables to completion
• Detail-oriented while maintaining awareness of broader scientific, regulatory, and commercial implications
• Builds strong cross-functional relationships and influences stakeholders through sound scientific rationale and data-driven arguments
• Demonstrates accountability for own work and project outcomes; may mentor junior scientists and provide technical guidance

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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.

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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.