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)
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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
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 quality mindset
Extensive hands-on experience with solid dosage form manufacturing processes
Demonstration of cross-functional understanding related to drug development
Must have significant technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules
Expert familiarity with analytical methods, validation, technology transfers and stability programs are needed
Management experience in strategic planning, budgets, project management plus regulatory experience in preparing and authoring the drug product sections of INDs and NDAs
Holds self accountable for mistakes of self and department and can set targets and articulate results
Must have expert understanding of cGMPs relating to late drug product manufacturing
Assimilates data and research findings outside of Neurocrine for application to new scientific projects
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
May develop an understanding of other areas and related dependencies
Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
Ability to work as part of and lead multiple teams
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture, impact on multiple programs, teams and/or departments
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management and leadership skills
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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.
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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.