Sr. Scientist, Pharmaceutical Development

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:

Serve as a senior technical leader within Pharmaceutical Development, representing CMC project teams across the product lifecycle from early discovery through commercialization and lifecycle management. Provide strategic and scientific leadership in process development, material characterization, and analytical strategies to enable phase-appropriate development, manage developability risks, and support intellectual property and commercial objectives. Establish and oversee CRO/CMO/CDMO partnerships, supporting technical transfer and manufacturing readiness. Represent CMC on cross-functional teams to deliver high-quality drug products that address molecule-specific challenges and meet regulatory and commercial objectives. _

Your Contributions (include, but are not limited to):

Provide scientific and technical leadership across drug product development programs from early discovery through commercial launch, ensuring alignment with program goals, timelines, and regulatory expectations

Lead weekly or bi-weekly internal and NBI–CMO/CDMO project team meetings; clearly communicate program progress, risks, resource gaps, and timelines up and down the organization

Design, develop, and scale robust, phase-appropriate formulations and manufacturing processes using Quality by Design (QbD) principles, statistical analysis, and sound scientific methodologies, with a clear path to commercialization

Lead and contribute to process development activities including experimental design (DoE), process modeling, scale-up, validation, and technology transfer to internal and external manufacturing sites

Serve as a subject matter expert (SME) to investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities; drive root cause analysis and implement effective solutions

Oversee and collaborate with external partners, including CDMOs and vendors, to ensure appropriate technical capabilities, quality, compliance, and supply of clinical and commercial materials

Act as technical lead and company representative during manufacturing campaigns and on-site activities (“person-in-plant”), providing oversight and ensuring successful execution

Collaborate cross-functionally with internal teams (e.g., Discovery, Chemical Development, Analytical, Clinical, Regulatory, Quality, and Supply Chain) to advance programs and ensure effective knowledge transfer across development stages

Lead or support CMC strategy and execution, including authorship and review of regulatory submissions (e.g., IND, IMPD, NDA, MAA) and development documentation, ensuring scientific rigor and compliance with global regulatory requirements (ICH, FDA, EMA, cGMP)

Drive continuous process verification (CPV) and continuous improvement (CPI) activities through data analysis and monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs)

Provide technical guidance, mentorship, and leadership to team members

Perform other duties as assigned

Requirements:

BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 6+ 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 4+ years of similar experience noted above OR

PhD in Chemistry, Biochemistry, Chemical Engineering, or related field AND 2+ years of similar experience noted above; may include postdoc experience

Advanced and comprehensive understanding of cGMP requirements across early- and late-stage drug product manufacturing, with a strong quality and compliance mindset

Deep technical expertise in product development, including process design, optimization, scale-up, validation, and lifecycle management

Strong cross-functional understanding of drug development from discovery through commercialization, including CMC strategy and regulatory lifecycle considerations

Expertise managing CROs and CMOs/CDMOs supporting preclinical, clinical, and commercial programs

Advanced knowledge of analytical methods, method validation, technology transfer, and stability programs

Extensive knowledge of characterization instrumentation and techniques; evaluates and implements emerging technologies to enhance development capabilities

Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions

Experience contributing to strategic planning, budget management, and portfolio-level decision-making

Experience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs

Assimilates external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs

Maintains broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplines

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

Holds self and team accountable for results; sets clear objectives and articulates measurable outcomes

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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 $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties