Sr. Scientist, Product Development - Early Stage

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Collaborate with Research/Discovery, Chemical Development, Analytical Development, and Product Development to facilitate communications between departments and lines, ensuring information is shared and used widely and effectively

• Execute thermodynamic and kinetic solubility studies for potential lead drug development candidates

• Prepare and evaluate formulations for administration in preclinical studies

• Research new instrumentation and formulation technologies to be implemented when needed for development support

• Evaluate powder properties of API and DP intermediates to determine the potential impact on later stage operations common in formulation development

• Assemble and maintain preformulation information repository to allow efficient retrieval of development reports, protocols, memos, specifications, and other relevant documentation

• Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of early product development

• Source, procure, install, qualify, operate, and maintain instrumentation and equipment required for preformulation and material science activities, as needed

• Lead or participate in weekly or bi-weekly project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines

• Review CMC regulatory documents, batch records, specifications, development protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirements

• Must have a good understanding of cGMPs relating to early drug product manufacturing

• May train lower level scientists

• Performs other duties as assigned

• BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 5+ years of pharmaceutical industry experience, including experience in a chemistry, analytical, or characterization laboratory setting. Extensive experience with the following instrumentation and techniques is preferred; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM. Previous project management / leadership experience is preferred OR

• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 3+ years of similar experience noted above OR

• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and some relevant experience; may include postdoc experience

• Hands-on experience with solid dosage form manufacturing processes

• Demonstration of cross-functional understanding related to drug development

• Must have technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules

• Familiarity with analytical methods, validation, technology transfers and stability programs are needed

• Management experience in strategic planning, budgets, project management plus regulatory experience in preparing and authoring the drug product sections of INDs and NDAs

• Holds self accountable for mistakes of self and department and can set targets and articulate results

• Must have a good understanding of cGMPs relating to early drug product manufacturing

• Strong knowledge of the following instrumentation and techniques is preferred; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM.

• 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 or more scientific disciplines, becoming expert in one discipline

• Strong knowledge of scientific principles, methods and techniques

• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Ability to work as part of a team; may train lower levels

• Excellent computer skills

• Strong communications, problem-solving, 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

• Effective report writing and oral presentations 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

• Understands how to effectively negotiate, persuade, and influence

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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