Scientific Director, Analytical Development

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Recognized as a scientific expert and leader in advanced analytical technologies for Chemistry, Manufacturing and Controls (CMC) development. Serve as an analytical lead leading multiple projects and/or lead a sub-team in analytical development to guide analytical activities. Develops strategy and driving execution for analytical activities internally and externally associated with process and formulation development in support of clinical manufacturing of drug substance and drug product for small molecule and peptides drug candidates to support preclinical studies, clinical development, registration, and commercialization. Provides scientific leadership for junior scientific staff. Serves on cross functional CMC teams responsible for analytical related CMC strategy and deliveries, including regulatory submissions. Responsible for development and implementation of analytical control strategies including specification setting and method development, with special emphasis on innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects. _ Your Contributions (include, but are not limited to): Leads analytical development activities for small molecules and peptides and serves as the analytical representative for cross-functional technical development teams which will include representatives from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality assurance organizations Oversees analytical method development, validation and transfer, specification strategy, GMP testing, and stability studies for drug substance and drug product internally and externally Directs the use of established and new techniques including HPLC/UPLC, LC-MS, GC, spectroscopy, NMR, dissolution, wet chemistry, physical characterization techniques (e.g., PXRD) to generate and interpret data Solves complex problems and devises control strategies to ensure drug substance and drug product quality Effectively interacts with multiple functions across the organization and effectively communicates results and strategies to staff and company executives Key contributor to and a resource for CMC sections in regulatory dossiers Leads external relationships with contract development and manufacturing organizations (CDMO) to drive analytical activities, including method transfer, batch release, and stability studies Manages physicochemical characterization of drug substance and related compounds Coaches team members and establishes a high performing team environment Overseeing analytical method development and characterization for small molecules and peptides Other duties as assigned Requirements: BS/BA degree in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 12 years’ experience the pharmaceutical industry, including managing pharmaceutical analytical method testing, qualification, and troubleshooting. Experience in assessing technical data to provide technical reviews of analytical data, documents, and regulatory submissions. Extensive previous managerial experience also required OR Masters in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 10 years of similar experience noted above OR PhD in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 7 years of similar experience noted above Ability to oversee and manage multiple programs/projects and being more independent on daily interactions with internal functional teams and external analytical CDMOs Proven success managing internal/external lab personnel Expert knowledge of analytical method development, method validation, and characterization of drug substances, drug products, and related substances Demonstrated expertise in key technologies such as HPLC/UPLC, LC-MS, GC, spectroscopy, solid state characterization, and dissolution Strong knowledge of ICH, FDA and EMA guidance for analytical method validation, stability, CTD, and submission of analytical data Ability to assess technical data to provide oversight of technical reviews of analytical data, documents, and regulatory submissions Broad knowledge of formulation development for drug products with various dosage forms Strong knowledge of cGMPs, including CMC regulatory information required for INDs/NDAs/ANDAs with respect to drug substance, pre-formulation, formulation, analytical methods, and dosage form manufacturing processes Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of technical expertise and pharmaceutical development to solve critical issues having cross-functional impact Ability to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives Strong attention to detail, excellent written and oral communication skills Strong leadership, coaching, employee development skills Ability to work in a cross functional team and matrix environment and influence others with or without authority at all levels of the organization Proactive, innovative, with good problem-solving skills Excellent written, presentation, and verbal communication skills Knowledge in analytical methodologies for characterizations of large molecules including peptides, proteins, and antibodies is a plus #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 $154,600.00-$211,000.00. 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 35% 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. We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!

Salary : $154,600 - $211,000