Principal Scientist, Analytical Development

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 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)

About the Role:Responsible for leading analytical development activities for multiple projects to support drug substance development from preclinical through commercial phase, with a focus on small molecules. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API. Responsible for development and implementation of control strategies, with special emphasis on advancing 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.

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

• Plans and manages projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects

• Independently designs, plans and executes activities towards the goals of one or more analytical chemistry projects to support pre-clinical through commercial activities, as well as contributing to overall control strategy

• Supervises laboratory work and/or lab personnel and ensures safe laboratory practices

• Performs analytical development and optimizes methods in support of preclinical through commercialization

• Creates and implements novel ideas and techniques to support analytical activities with API Development

• Provides support for off-site analytical transfers, manufacturing support and interaction with contractors

• Provides input into CMC regulatory documentation and supporting work

• Provides effective supervision of laboratory personnel and guidance for their professional development

• Contributes to development of policies and department strategies

• Builds and enhances internal and external professional relationships

• Presents finding at varying levels across the company

• Supports career development and technical growth of direct reports

• Other duties as assigned

Requirements:

• BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR

• MS/MA in Analytical Chemistry or related discipline and 10+ years of experience OR

• PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience

• Thorough understanding of analytical chemistry and a well-developed understanding of process chemistry

• Proficiency in one or more techniques for drug substance characterization, such as LC, GC, IR, MS, NMR, KF, UV etc.

• Excellent interpersonal skills with strong oral and written communication abilities

• Excellent laboratory and productivity skills

• Strong technical expertise in method development/validation/transfer experience in Analytical Development

• Good understanding of cGMP requirements in API and drug product

• Demonstration of cross-functional understanding related to drug development

• 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 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 $130,800.00-$179,000.00. 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.