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

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.

_

Your Contributions (include, But Are Not Limited To)

• Develops and executes instrumental methods (e.g. HPLC, dissolution, etc.) 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.)
• Accurately follows established test methods, procedures, regulatory guidance’s (e.g. ICH), and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
• With supervision and independently, plans and executes laboratory testing of in-house analytical method development activities, analytical method validation, stability studies for drug products, and formulation development support
• With supervision and independently, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
• With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development
• Recognizes fundamental anomalies in data points, inconsistent results, and identifies issues in experiments / processes
• Able to interpret experimental outcomes and communicate results to broader team
• Create and review technical reports and oral presentations of various analytical activities (e.g. method development reports, investigations, results summary, etc.)
• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs), GxP expectations, and training
• Provides detailed reviews of peer generated data as well as that generated from contracted service providers
• Performs other duties as assigned
  
  

Requirements

• BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above OR
• PhD in chemistry or closely related field and some industry or relevant experience a plus
• 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
• Demonstration of cross-functional understanding related to drug development
• Practical working knowledge of conducting HPLC analysis and troubleshooting
• Capable of evaluating analytical data and drawing meaningful conclusions
• Knowledge of cGMP expectations for laboratory records and quality systems
• Ability to provide ideas for process improvements
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
• Good knowledge of scientific principles, methods and techniques
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools, including: HPLC, dissolution apparatus per USP, Karl Fisher
• Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
• Strong 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
  
  

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 $88,000.00-$127,550.00. 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.