Scientist II, Pharmaceutical Development

Neurocrine Biosciences•San Diego, CA

About The Position

Neurocrine Biosciences is seeking a Scientist II to represent Product Development on CMC project teams and provide formulation and analytical expertise across preclinical and clinical programs. The role spans development from early discovery through commercial launch, designing and executing preformulation and formulation studies to deliver phase-appropriate, safe, therapeutically effective dosage forms that support regulatory progression and commercialization. The scientist leads development and optimization of manufacturing processes for pharmaceutical compounds, using knowledge of material properties and operating parameters to ensure robust performance through development, scale-up, and commercial readiness. The position works closely with internal cross-functional teams and external CDMO partners, applies Quality by Design principles, supports technology transfer and manufacturing campaigns, and prepares development documentation and regulatory submissions. The role may also include mentoring or training junior scientists.

Requirements

Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related field and 4 or more years of pharmaceutical industry experience, including chemistry, analytical, or characterization laboratory experience; or a master's degree in one of these fields and 2 or more years of similar experience; or a PhD in one of these fields with some relevant experience, which may include postdoctoral 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 developing pharmaceutical manufacturing processes.
Cross-functional understanding of drug development from discovery through commercialization, including CMC strategy and lifecycle management.
Experience supporting or leading technology transfer to pilot, clinical, or commercial manufacturing sites and/or CDMOs.
Strong working knowledge of Quality by Design principles and application of statistical analysis software and risk assessment tools across the product lifecycle.
Familiarity with analytical method development, validation, stability programs, and characterization techniques.
Experience contributing to regulatory submissions such as IND, NDA, or 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.
Ability to align scientific activities with project, functional, and CMC program goals and broader development and regulatory strategy.
Ability to identify anomalous or inconsistent data, determine root causes, and implement scientifically sound solutions with minimal oversight.
Technical expertise in at least one scientific discipline and ability to apply deep scientific knowledge to complex formulation and process challenges.
Strong command of scientific principles, methods, and techniques, with ability to translate theory into practical development solutions.
Proficiency with a broad range of laboratory, analytical, and pharmaceutical manufacturing equipment, including independent troubleshooting of technical and operational issues.
Strong analytical thinking and creative problem-solving skills in a cross-functional, matrix environment.
Excellent written and verbal communication skills, including technical report preparation and scientific presentations.
Effective project management skills, including management of multiple programs, prioritization of competing deadlines, and delivery of commitments.
Attention to detail while maintaining awareness of broader scientific, regulatory, and commercial implications.
Ability to build cross-functional relationships and influence stakeholders using sound scientific rationale and data-driven arguments.
Accountability for work and project outcomes; ability to provide technical guidance and potentially mentor junior scientists.

Responsibilities

Represent Product Development on CMC project teams across development stages, from early discovery through commercial launch.
Collaborate with Research/Discovery, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, Supply Chain, and external CDMO partners to advance programs and align stakeholders.
Design and execute preformulation and formulation development studies that deliver phase-appropriate dosage forms aligned with target product profiles.
Plan and execute studies using Quality by Design principles, including Design of Experiments, to optimize formulations and manufacturing processes.
Prepare, evaluate, and optimize preclinical and clinical formulations and assess downstream manufacturability risks.
Lead pilot-scale and commercial process scale-up and support technical transfer activities.
Represent the company during on-site CDMO manufacturing campaigns, ensuring adherence to partner SOPs and effective technical communication.
Research, evaluate, source, procure, install, qualify, operate, and maintain instrumentation and emerging formulation technologies.
Prepare, review, and maintain laboratory notebooks, protocols, reports, specifications, batch records, and CMC regulatory submissions in compliance with cGMP and global regulatory requirements.
Maintain organized repositories of formulation and material characterization data, development reports, and process knowledge.
Lead or participate in project team meetings and communicate progress, risks, timelines, and resource needs to stakeholders and leadership.
Mentor or train junior scientists as appropriate.
Perform other duties as assigned.