Sr. Principal Scientist, Tech Transfer

About the role

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 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 ) Leads the design and execution of complex formulation and process development activities across the full product lifecycle, from early discovery through commercialization, delivering phase-appropriate, high-quality drug products that address molecule-specific challenges and target product profiles. Oversees end-to-end development including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while establishing and managing external partnerships to support clinical and commercial programs. Provides strategic and technical leadership within CMC teams, driving cross-functional alignment, regulatory readiness, and continuous improvement, while mentoring team members and ensuring robust control strategies for long-term product performance and supply. _ Your Contributions (include, but are not limited to): Lead formulation and process development across the product lifecycle, designing and optimizing phase-appropriate, robust drug product formulations and manufacturing processes aligned with target product profiles and program objectives Serve as the technical and strategic lead within CMC teams, guiding scientific strategy, managing subteams, and driving program execution through effective planning, communication, and decision-making Oversee process development activities including experimental design (DoE), scale-up, validation, and global technology transfer, ensuring successful execution from early development through commercial manufacturing Provide subject matter expertise to investigate and resolve complex technical challenges, applying innovative and data-driven approaches to overcome development obstacles and ensure product quality Establish and manage external partnerships (e.g., CDMOs, CROs), including selection, oversight, and performance management to ensure technical capability, compliance, and reliable supply Act as company representative during manufacturing campaigns and external engagements ("person-in-plant"), ensuring operational excellence and alignment with development and commercial goals Drive cross-functional collaboration with internal teams and external partners to advance programs efficiently and ensure seamless knowledge transfer Lead development and execution of CMC regulatory strategies, including authorship, review, and oversight of submissions, ensuring compliance with global regulatory requirements and scientific integrity Implement lifecycle management strategies, including continuous process verification, continuous improvement, and proactive risk management for critical process parameters and quality attributes Identify and implement new technologies, equipment, and development approaches to enhance organizational capabilities, innovation, and competitiveness Establish and maintain effective knowledge management systems, documentation standards, and best practices to support data integrity, accessibility, and regulatory readiness Provide leadership, mentorship, and technical guidance to team members, while influencing broader organizational strategy and representing the company in external scientific and regulatory forums Other duties as assigned

Requirements

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting OR
• Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years of similar experience noted above OR
• PharmD preferred and 4+ years of similar experience noted above
• Must have in depth knowledge and a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong qualit

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