Associate 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 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:

Under direct supervision, is responsible for development and execution of analytical test methods that facilitate drug product development / manufacturing and regulatory submissions for clinical study introduction through phase III trials. Activities includes test method development, qualification/validation, transfer and execution. Supports late stage troubleshooting and development of products, processes, and methods in support of product commercialization.

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

• With direct supervision, develops and executes chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR, Water Content) of analyses of drug product development compounds

• Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution, Content Uniformity) to generate data essential for strategic decision making

• With direct supervision, plans and executes forced degradation, informal stability, and excipient compatibility studies

• With direct supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results

• With direct supervision, collaboratively plans and executes cross functional studies for formulation development

• Recognizes and responds to unexpected or anomalous observations in all activities

• Maintains complete and accurate records of laboratory work in conformance with company SOPs and training

• Provides detailed reviews of peer generated data as well as that generated from contracted service providers

• Other duties as assigned

Requirements:

• BS/BA degree in chemistry or closely related field and some relevant industry experience preferred; Experience with Empower a plus

• Working knowledge of data systems for computer-controlled instrumentation

• Familiarity with performing analytical testing of solid oral drug products; Hands-on knowledge preferred

• Knowledge of conducting HPLC analysis and troubleshooting. Working knowledge of performing stability indicating method development a plus

• Familiarity with performing dissolution analysis and troubleshooting. Hands-on knowledge performing dissolution method development a plus

• Understanding of analytical data evaluation and ability to draw meaningful conclusions

• Ability to present analytical data clearly and demonstrate knowledge of the testing and the product

• Knowledge of cGMP expectations for laboratory records and quality systems

• Knowledge of ICH guidance and common testing per USP chapters

• Knowledge of statistical analysis a plus

• Ability to provide ideas for process improvements

• Able to execute experiments efficiently and suggest small process improvements

• Able to recognize patterns or inconsistencies in data results

• Able to deduce meaningful results while conducting routine analyses or troubleshoot minor issues. Good knowledge of one scientific discipline

• Developing knowledge of scientific principles, methods and techniques

• Good knowledge and some experience working with discipline specific laboratory equipment/tools

• Ability to work as part of a team

• Good computer skills

• Developing communications, problem-solving, analytical thinking, planning and organization skills

• Detail oriented

• Understands importance of meeting deadlines

• Proficient using MS-Excel, MS-Word

• Ability to work with a team of individuals to meet goals

• Ability to accomplish tasks in a timeline driven setting

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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 hourly rate we reasonably expect to pay is $35.35-$47.34. 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 15% 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.