Scientist II, Pharmaceutical Development

Neurocrine Biosciences•San Diego, CA

1d•$110,800 - $151,000

About The Position

Neurocrine Biosciences is seeking a Scientist II, Pharmaceutical Development to represent Product Development on CMC project teams throughout the development lifecycle, from early discovery through commercial launch. The role provides formulation and analytical expertise to preclinical and clinical programs, and designs and executes preformulation and formulation studies to deliver phase-appropriate, safe, therapeutically effective dosage forms that support regulatory progression and commercialization. The position leads development and optimization of manufacturing processes for pharmaceutical compounds. It applies knowledge of material properties and operating parameters to understand their effects on critical quality attributes and support robust performance through development, scale-up, and commercial readiness. The Scientist collaborates with internal functions and external CDMO partners, contributes to technology transfer and regulatory documentation, and communicates program progress, risks, timelines, and resource needs to project teams and leadership. The role may also mentor or train junior scientists.

Requirements

BS/BA in Chemistry, Biochemistry, Chemical Engineering, or a related field and 4+ years of pharmaceutical industry experience, including experience in a chemistry, analytical, or characterization laboratory; or MS/MA in one of these fields and 2+ years of similar experience; or PhD in one of these fields and 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 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 QbD 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, and 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 to internal and external stakeholders.
Project management skills, including managing multiple programs, prioritizing competing deadlines, and driving deliverables to completion.
Attention to detail while maintaining awareness of broader scientific, regulatory, and commercial implications.
Ability to build cross-functional relationships and influence stakeholders through scientific rationale and data-driven arguments.
Accountability for work and project outcomes; ability to mentor junior scientists and provide technical guidance.

Responsibilities

Collaborate with Research/Discovery, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, Supply Chain, and external CDMO partners to advance programs and maintain effective communication and alignment.
Design and execute preformulation and formulation development studies using first principles and target product profiles to deliver phase-appropriate dosage forms.
Plan and conduct studies using Quality by Design (QbD) principles, including Design of Experiments (DOE), to optimize formulations and manufacturing processes.
Prepare, evaluate, and optimize formulations for preclinical and clinical use, and assess downstream manufacturability risks.
Lead pilot-scale and commercial process scale-up and 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 development documentation, including laboratory notebooks, protocols, reports, specifications, batch records, and CMC regulatory submissions, in compliance with cGMP and global regulatory requirements.
Maintain organized repositories for 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.