Principal Engineer, Pharmaceutical Development – Solid Oral Drug Products

Neurocrine Biosciences•San Diego, CA

3d•$156,900 - $214,000

About The Position

Neurocrine Biosciences is seeking an experienced Principal Engineer to provide scientific expertise, technical leadership, and strategic guidance across multiple drug development programs. As a senior technical leader and subject matter expert within Pharmaceutical Development, the Principal Engineer represents Technical Operations on cross-functional project teams. The role focuses on late-stage development, from Phase 2/3 clinical manufacturing through process optimization, scale-up, characterization, and control strategy development. It supports regulatory submissions, commercial readiness, and transition of programs to Manufacturing Science and Technology (MSAT) for process validation and lifecycle management. The Principal Engineer collaborates with Pre-formulation, Formulation Development, Analytical Development, MSAT, other Technical Operations functions, and external CDMO partners to address development challenges and develop robust, scalable, reproducible solid oral drug product manufacturing processes. The position applies Quality by Design (QbD), Design of Experiments (DoE), predictive modeling, and risk-based approaches to process development and control strategy development. It contributes to regulatory submissions, technology transfer to MSAT, process validation support, intellectual property defense, and commercialization activities.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related field and at least 8 years of pharmaceutical industry experience in a process engineering setting; or a master’s degree in one of these fields and at least 6 years of similar experience; or a PhD in one of these fields and at least 4 years of similar experience, which may include postdoctoral experience.
Technical expertise in process development and GMP manufacturing.
Expertise in phase-appropriate process development and a strong understanding of powder properties and biopharmaceutics to determine relevant manufacturing steps for solid oral drug products.
Ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, IMPDs, NDAs, and other global submissions.
Strong knowledge and expertise with Compaction Simulators, Roller Compaction, Encapsulators, Tablet Presses, Fluid Beds, and Pan Coaters.
Ability to adapt to changing priorities and deadlines.
Ability to assimilate external scientific literature, competitive intelligence, and emerging technologies for use in internal development programs.
Understanding of related functional areas and interdependencies across drug development, manufacturing, and regulatory work.
Advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologies.
Ability to influence cross-functional and matrixed organizations and provide technical leadership to junior scientists, engineers, and indirect teams.
Strong leadership capability, strategic thinking, and organizational awareness.
Excellent computer proficiency and data analysis capability.
Ability to understand 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.

Nice To Haves

Strong cross-functional understanding of formulation development and analytical development of solid oral drug products.
Working knowledge of JMP software.
Experience with oral peptides.
Preferred equipment models include Style One Compaction Simulator, Gerteis Roller Compaction, Bosch Encapsulators, Korsch Tablet Presses, and Glatt Fluid Beds and Pan Coaters.
Working knowledge of spray drying, hot melt extrusion, powder properties (particle-size analysis, flow, and segregation potential), thermal analysis (DSC), solid fraction, and dissolution.

Responsibilities

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 programs.
Design and develop fit-for-purpose, phase-appropriate processes—including granulation, encapsulation, tablet compression, coating, spray drying, and hot melt extrusion—considering target product profiles, biopharmaceutics properties, and forecasted demand for FIH, POC, and pivotal clinical studies, and supporting transitions from clinical development to commercial manufacturing.
Identify process development risks using approaches such as FMEA, evaluate experimental findings, and recommend strategies for robust clinical manufacturing, scale-up, and process control.
Independently review experimental designs, analytical data, electronic laboratory notebooks, technical reports, and regulatory documentation; provide technical oversight of CDMO partners, including person-in-plant activities and master and executed batch record review.
Mentor junior scientists and engineers on experimental approaches, troubleshooting, data interpretation, scientific writing, and development best practices.
Collaborate with multidisciplinary Technical Operations teams, including Analytical Development, MSAT, External Operations, and Supply Chain, to communicate findings, anticipate risks and challenges, and influence program strategy and advancement.
Evaluate and implement innovative scientific approaches and process improvements to enhance development capabilities and efficiency.
Author and review experimental protocols, technical reports, scientific presentations, and regulatory submissions; support knowledge sharing and scientific excellence.
Support regulatory submissions, technology transfer to MSAT, process validation, intellectual property defense, and commercialization activities.
Perform other duties as assigned.