Scientist/Sr. Scientist, 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:

An Analytical Scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. Responsible for performing analytical laboratory activities to support manufacturing of drug products intended for use in clinical studies (all phases). Develops, establishes, and validates testing methodology used to control final drug products. Establishes, validates, and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements.

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

• Responsible for in-house analytical development laboratory activities to support manufacturing of drug products intended for use in clinical studies

• Responsible for conducting in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.)

• Work closely with Pharmaceutical Development counterparts

• Develops and validates test methods at NBI for solid oral drug products

• Supports formulation development

• Identification of degradants in drug product

• Analytical technology transfer to CSP

• Overviews GMP analytical testing of clinical supplies by CSPs

• Facilitates and leads investigations for out of specification and out of trend results

• Prepares of the analytical sections of regulatory documents, protocols and reports

• Provides training and/or supervision to junior staff, as needed

• Other duties as assigned

Requirements:

• BS/BA degree in chemistry or closely related field and 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry. Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms. Previous supervisory and/or project management experience is preferred OR

• MS/MA degree in chemistry or closely related field and

  3+ years of similar experience noted above OR

• PhD or equivalent in chemistry or closely related field and some relevant experience; may include postdoc experience

• Effective report writing and oral presentations skills are required

• Excellent written and verbal communication skills are required

• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company

• Ability to creatively solve complex problems in a team environment

• Demonstration of cross-functional understanding related to drug development

• Effectively see projects to completion

• Understands how to effectively negotiate, persuade, and influence

• Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms

• A working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issues

• Must have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD

• Demonstrates solid level of understanding project / group goals and methods

• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes

• Able to explain the process behind the data and implications of the results

• Strong knowledge of one of the following scientific disciplines: HPLC analytical development and/or dissolution development

• Strong knowledge of scientific principles, methods, and techniques

• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools, primarily HPLC/UHPLC, Karl Fischer, and dissolution apparatus (manual and automated)

• Strong laboratory documentation, in line with cGMP practices

• Ability to work as part of a team

• Ability to lead teams

• Excellent computer skills

• Strong communication, problem-solving, and analytical thinking skills

• Detail oriented yet can see broader picture of scientific impact on team

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Strong 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 dont 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 $108,600.00-$157,350.00. 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 20% 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.