Associate Scientific Director API Development, MSAT

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:

The Associate Scientific Director, Manufacturing Science & Technology (MSAT) provides technical leadership across the product lifecycle of API synthetics to ensure robust, scalable, and compliant manufacturing of commercial and late-stage clinical API. This role leads technology transfer, process validation, lifecycle management, continuous improvement, and manufacturing support across global external manufacturing networks. This leader partners across Technical Development, External Operations, Quality, Regulatory Affairs, and Supply Chain to enable successful commercialization, reliable product supply, and continuous process excellence. The position combines scientific and engineering expertise with strategic leadership to develop organizational capabilities, drive innovation, and support corporate objectives.

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

Technical Leadership

• Lead the development and execution of manufacturing science and technology strategies supporting commercial manufacturing and lifecycle management

• Serve as the technical authority for late-stage clinical and commercial manufacturing processes across API synthetics

• Translate laboratory and pilot-scale processes into robust, scalable, validated, and commercially sustainable manufacturing operations

• Lead technical assessments, root cause investigations, complex troubleshooting, and implementation of innovative engineering and process solutions

• Develop manufacturing control strategies that ensure product quality, process robustness, and regulatory compliance

Technology Transfer & Commercialization

• Lead end-to-end technology transfer activities from Technical Development through commercial manufacturing

• Establish commercial manufacturing readiness by coordinating process validation, engineering studies, comparability assessments, and manufacturing campaigns

• Partner with Contract Development and Manufacturing Organizations (CDMOs) to ensure successful process implementation

• Provide technical oversight during product launches, capacity expansions, and manufacturing network transfers

Process Optimization & Continuous Improvement

• Drive process optimization initiatives that improve manufacturing robustness, product quality, yield, reliability, and cost of goods

• Lead cross-functional continuous improvement programs utilizing science- and risk-based methodologies

• Identify process vulnerabilities and implement corrective and preventive actions that improve operational performance

• Champion Lifecycle Management (LCM) strategies supporting product enhancements, post-approval changes, and manufacturing sustainability

Regulatory & Quality Support

• Provide technical leadership supporting global regulatory submissions, inspections, and responses

• Author and review technical reports, validation documentation, regulatory filings, comparability protocols, and change control documentation

• Ensure manufacturing processes remain compliant with global cGMP regulations and evolving regulatory expectations

• Partner with Quality to investigate deviations, implement CAPAs, and maintain inspection readiness

Technical Leadership

• Develop and execute departmental strategies aligned with Technical Operations and corporate objectives

• Lead complex cross-functional initiatives supporting commercialization, supply reliability, and portfolio growth

• Influence organizational strategy through scientific leadership, technical governance, and data-driven decision making

• Build strong partnerships across Technical Operations, Regulatory Affairs, Quality, and Commercial organizations

Organizational Leadership

• Build, develop, and mentor high-performing engineering and scientific partnerships

• Foster a culture of technical excellence, innovation, collaboration, and continuous learning

• Develop organizational capabilities that support emerging technologies, new modalities, and future portfolio needs

Success Measures

• Success in this role will be demonstrated through:

• Successful commercialization and technology transfer of new products

• Reliable commercial manufacturing performance

• Improved process capability, yield, and operational efficiency

• Successful regulatory inspections and submissions

• Effective lifecycle management and continuous improvement initiatives

• Development of high-performing technical teams

• Strong cross-functional partnerships that accelerate delivery of medicines to patients

Requirements:

• BS/BA in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 14+ years of similar experience noted above OR

• MS/MA in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 8+ years of relevant experience OR

• PhD in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 6+ years of relevant experience

• Relevant experience includes:

• Manufacturing Science & Technology (MSAT)

• Commercial pharmaceutical manufacturing

• Technology Transfer

• Process Validation

• Process Engineering

• Lifecycle Management

• External Manufacturing / CDMO oversight

• Regulatory submissions and inspections

• Continuous Improvement / Operational Excellence

Technical Expertise

• Advanced knowledge of pharmaceutical process development, scale-up, validation, and commercial manufacturing

• Expertise in Manufacturing Science & Technology (MSAT), process engineering, technology transfer, and lifecycle management

• Strong understanding of cGMP regulations, Quality Systems, Process Validation, Continued Process Verification, and regulatory requirements

• Demonstrated experience supporting clinicalcommercial manufacturing operations and post-commercialization process improvements

• Expertise in risk management, statistical analysis, root cause investigations, and data-driven decision making

Leadership Competencies

• Proven ability to lead complex technical organizations and cross-functional programs

• Strategic thinker capable of balancing technical excellence with business priorities

• Exceptional communication and executive presentation skills.

• Strong collaboration, negotiation, and stakeholder management capabilities

• Demonstrated success influencing senior leadership and external partners

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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.