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Associate Scientific Director API Development, MSAT
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Full-time
bachelor degree, postgraduate degree
Posted 2d ago
~40 hrs/week
Responsibilities
The Associate Scientific Director provides technical leadership for API synthetic manufacturing, overseeing technology transfer, process validation, and lifecycle management. This role partners with cross-functional teams and external CDMOs to ensure robust, compliant, and scalable manufacturing operations.
Requirements
Candidates must hold a BS, MS, or PhD in chemistry, biology, or chemical engineering with 6 to 14+ years of relevant experience in MSAT and pharmaceutical manufacturing. Strong expertise in cGMP regulations, process development, and leadership of complex technical organizations is required.
Full 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:
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
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
#LI-OS1
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.
Related keywords
API SyntheticsMSATBiopharmaceuticalTechnology TransferProcess ValidationLifecycle ManagementcGMPCDMORegulatory AffairsQuality SystemsProcess EngineeringRoot Cause AnalysisRisk ManagementStatistical AnalysisTechnical OperationsCommercial Manufacturing
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 patients with 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 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.
Review our Community Guidelines: https://bit.ly/NeurocrineLinkedInGuidelines
*in collaboration with AbbVie
Offices: 6027 Edgewood Bend Ct, San Diego, California 92130, US
Movement DisordersCNSNeurologyEndocrinologyand ImmunologyHealth CareBiotechnologyMedicalPharmaceutical
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