Principal Engineer, Pharmaceutical Development - Solid Oral Drug Products

Neurocrine Continental; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurocrine Biosciences seeks a Principal Engineer, Pharmaceutical Development for solid oral drug products. Lead technical strategy from late-stage development through scale-up and process validation, partnering with MSAT and external CDMOs to ensure robust manufacturing processes.

The role emphasizes QbD, DoE, predictive modeling and strong regulatory support to advance programs toward commercialization with cross-functional collaboration.

Qualifications

• BS/BA in Chemistry, Biochemistry or Chemical Engineering.
• Experience in pharmaceutical development and process development.
• Strong writing and data interpretation for technical reports.

Responsibilities

• Serve as SME in process engineering for solid oral drug products.
• Design phase-appropriate processes (granulation, encapsulation, tablet coating).
• Identify process risks (FMEA) and propose robust strategies.
• Review experimental designs, analytical data and regulatory documentation.
• Mentor junior scientists and engineers in development best practices.
• Collaborate with Analytical Development, MSAT and CDMO partners.

Skills

Process engineering

Pharmaceutical development

Quality by Design

DoE

Regulatory submissions

Cross-functional collaboration

Education

BS/BA in Chemistry, Biochemistry, Chemical Engineering

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Neurocrine Biosciences is seeking an experienced Principal Engineer, Pharmaceutical Development - Solid Oral Drug Products to provide scientific expertise, technical leadership, and strategic guidance across multiple drug development programs.

The Principal Engineer will serve as a senior technical leader and subject matter expert within Pharmaceutical Development, representing Technical Operations on cross-functional project teams. The role will focus on late-stage development, from Phase 2/3 clinical manufacturing through process optimization, scale-up, characterization, and control strategy development, supporting regulatory submissions, commercial readiness, and the transition of programs to Manufacturing Science and Technology (MSAT) for process validation and lifecycle management.

The successful candidate will collaborate closely with Pre-formulation, Formulation Development, Analytical Development, MSAT, other Technical Operations functions, and external CDMO partners to address complex development challenges and develop robust, scalable, and reproducible manufacturing processes for solid oral drug products.

Leveraging extensive pharmaceutical industry experience, the Principal Engineer will apply Quality by Design (QbD), Design of Experiments (DoE), predictive modeling, and risk-based approaches to advance process development and establish robust control strategies. The role will also contribute to regulatory submissions (INDs, IMPDs, NDAs, MAAs, etc.), facilitate technology transfer to MSAT, and provide technical support for process validation, intellectual property defense, and commercialization activities.

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

• Serve as a scientific subject matter expert in process engineering and pharmaceutical development of solid oral drug products, providing technical guidance, strategic recommendations, and data driven decisions across multiple drug development programs
• Design and develop fit-for-purpose phase-appropriate processes (granulation, encapsulation, tablet compression, coating, spray drying, hot melt extrusion, etc.) considering target product profiles, biopharmaceutics properties, and forecasted demands in support of FIH, POC, and pivotal clinical studies as well as providing support for transitioning programs from clinical development to commercial
• Apply broad pharmaceutical development experience to identify process development risks (FMEA), evaluate experimental findings, and recommend strategies that support robust clinical manufacturing, scale up, and process control
• Provide independent scientific review of experimental designs, analytical data, electronic laboratory notebooks, technical reports, and regulatory documentation as well as technical oversight of CDMO partners, including person in plant activities and master/executed batch record review, to ensure scientific rigor and quality
• Serve as a technical mentor to junior scientists/engineers, providing guidance on experimental approaches, troubleshooting, data interpretation, scientific writing, and development best practices
• Collaborate with multidisciplinary Technical Operations teams (Analytical Development, MSAT, External Operation and Supply Chain, etc.) to communicate scientific findings, anticipate potential development risks/challenges, and influence program strategy and advancement
• Evaluate and implement innovative scientific approaches and process improvements to enhance pharmaceutical development capabilities and efficiency
• Author and review experimental protocols, technical reports, scientific presentations, and relevant regulatory submissions while supporting knowledge sharing and scientific excellence across the organization
• Other duties as assigned

Requirements:

BS/BA degree in Chemistry, Biochemistry, Chemical Engi