Sr. Scientist, Pharmaceutical Development

Neurocrine Biosciences•San Diego, CA

1d•$130,800 - $179,000

About The Position

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.

Requirements

Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related field and 6 or more years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting; or
Master's degree in Chemistry, Biochemistry, Chemical Engineering, or a related field and 4 or more years of similar experience; or
Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or a related field and 2 or more years of similar experience; postdoctoral experience may count.
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, and ability to evaluate and implement emerging technologies to enhance development capabilities.
Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions.
Ability to assimilate external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs.
Broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplines.
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, and provide technical leadership to junior scientists and indirect teams.
Strong leadership capability, strategic thinking, and organizational awareness.
Excellent computer proficiency and data analysis capability.
Exceptional communication, analytical thinking, and complex problem-solving skills.
Ability to consider the broader organizational impact of decisions across programs, departments, and portfolios.
Ability to effectively 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.

Responsibilities

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; communicate program progress, risks, resource gaps, and timelines throughout 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 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 to investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities; drive root cause analysis and implement 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 with internal teams, including 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 such as IND, IMPD, NDA, and MAA submissions, and development documentation.
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.