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 Engineering, or related field and 8+ years of pharmaceutical industry experience, specifically in a process engineering setting OR
- MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 6+ years of similar experience noted above OR
- PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above; may include postdoc experience
- Strong cross-functional understanding related to formulation development and analytical development of solid oral drug products is strongly preferred. Must have technical expertise in process development and GMP manufacturing
- Working knowledge of JMP software is preferred
- Expertise with phase appropriate process development and strong understanding of powder properties and biopharmaceutics to determine relevant manufacturing steps to make solid oral drug products, experience with oral peptides is a differentiator
- Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
- Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, IMPDs, NDAs, and other global submissions
- Strong knowledge and expertise of the following instrumentation and techniques is required; Compaction Simulator (Style One preferred), Roller Compaction (Gerteis preferred), Encapsulators (Bosch preferred), Tablet Presses (Korsch preferred), Fluid Beds (Glatt preferred), and Pan Coaters (Glatt preferred)
- A working knowledge of the following is preferred; spray drying, hot melt extrusion, powder properties (Particle-Size Analysis, Flow, Segregation Potential), thermal analysis (DSC), solid fraction, and dissolution
- Proven ability to adapt to changing priorities and deadlines
- Assimilates external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs
- Understands related functional areas and interdependencies across drug development, manufacturing, and regulatory
- Demonstrates advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologies
- Proven ability to influence cross-functional and matrixed organizations; provides technical leadership to junior scientists/engineers and indirect teams
- Exhibits strong leadership capability, strategic thinking, and organizational awareness
- Excellent computer proficiency and data analysis capability
- Sees the broader organizational impact of decisions across programs, departments, and portfolios
- Effectively manages multiple high-priority programs simultaneously with accuracy, efficiency, and accountability
- Excellent project management skills, including long-range planning and execution
- Holds self and team accountable for results; sets clear objectives and articulates measurable outcomes
#LI-DM1
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
_
The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
