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. 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 cross-functional and external project-team meetings, communicate program progress and risks, and guide formulation and manufacturing-process design, development, scale-up, validation, and technology transfer. Serve as a subject matter expert in resolving technical issues, oversee external partners and manufacturing campaigns, and contribute to CMC strategy, regulatory submissions, continuous process verification, and process improvement. Provide technical guidance and mentorship to team members. The role requires a relevant chemistry, biochemistry, or chemical engineering degree and pharmaceutical industry experience, with the required experience level varying by degree. The position offers an annual base salary of $130,800 to $179,000, an annual bonus target of 30% of earned base salary, eligibility for an equity-based long-term incentive program, and benefits including retirement savings with company match, paid time off, leave, and health coverage.

Requirements

BS/BA in Chemistry, Biochemistry, Chemical Engineering, or a related field and 6 or more years of pharmaceutical industry experience in a chemistry, analytical, or characterization laboratory setting; or an MS/MA in one of these fields and 4 or more years of similar experience; or a PhD in one of these fields and 2 or more years of similar experience, which may include postdoctoral 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.
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 development programs.
Broad knowledge of scientific principles and theories, with 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, providing 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 assess the broader organizational impact of decisions across programs, departments, and portfolios.
Ability to 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.
Lead weekly or bi-weekly internal and NBI–CMO/CDMO project team meetings and communicate progress, risks, resource gaps, and timelines.
Design, develop, and scale phase-appropriate formulations and manufacturing processes using Quality by Design principles, statistical analysis, and scientific methodologies.
Lead and contribute to process development, including experimental design, process modeling, scale-up, validation, and technology transfer.
Investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities; drive root-cause analysis and solutions.
Oversee and collaborate with CDMOs and vendors to ensure technical capabilities, quality, compliance, and supply of clinical and commercial materials.
Act as technical lead and company representative during manufacturing campaigns and on-site person-in-plant activities.
Collaborate with Discovery, Chemical Development, Analytical, Clinical, Regulatory, Quality, and Supply Chain teams to advance programs and transfer knowledge.
Lead or support CMC strategy and execution, including authoring and reviewing regulatory submissions and development documentation.
Drive continuous process verification and continuous improvement through data analysis and monitoring critical process parameters and critical quality attributes.
Provide technical guidance, mentorship, and leadership to team members.
Perform other duties as assigned.