Principal Scientist, Product Development - Late Stage
: Job Details :

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for conditions such as tardive dyskinesia, Huntington's disease chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, along with a robust pipeline of clinical-stage compounds. With over three decades of expertise, we aim to treat complex conditions through innovative neuroscience solutions. For more information, visit neurocrine.com and follow us on LinkedInX, and Facebook. (*in collaboration with AbbVie)

About the Role:

Develop, design, and execute formulation and process studies to support development projects from Phase I through commercial. Manage product development programs with an emphasis on formulation, including screening, prototyping, scale-up, optimization, packaging, and stability testing. Establish relationships with CMOs and oversee process development and transfer for drug products. Represent CMC in project teams to deliver high-quality, phase-appropriate drug products addressing solubility, permeability, and target profile challenges.

Key focus areas include: solubility enhancement, modified release dosage forms, amorphous solid dispersions, self-emulsifying systems, low dose product design, dry granulation, tableting, and encapsulation.

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

• Develop and optimize formulations to meet project needs
• Lead project team meetings and communicate progress and challenges
• Investigate atypical results and troubleshoot formulation issues
• Evaluate and ensure outsourcing partners meet quality and capability standards
• Research new technologies and instrumentation for formulation development
• Present updates and technical talks within the department
• Collaborate across departments and with external partners to advance projects
• Oversee equipment purchase, installation, and maintenance, and mentor staff
• Author development reports, protocols, and regulatory documents
• Represent Product Development during manufacturing campaigns
• Perform other duties as assigned

Requirements:

• BA/BS in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field with 8+ years industry experience in late-phase product development, including solid dosage form expertise and experience managing CMOs.
• Master's degree with 6+ years or PhD with 4+ years of similar experience.
• Thorough understanding of cGMPs, regulatory guidelines, and quality standards.
• Hands-on experience with solid dosage manufacturing equipment.
• Strong analytical, data analysis, and project management skills.
• Knowledge of regulatory guidance (ICH, FDA, EMA) and experience in preparing regulatory documents.
• Leadership skills to manage teams and projects effectively.
• Excellent communication and problem-solving skills.

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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to diversity and inclusion, encouraging applications from all qualified candidates regardless of background.

The expected annual base salary range is $128,200.00-$185,900.00, with additional benefits including bonuses, equity incentives, retirement plans, paid leave, and comprehensive health coverage.