Specialist, Chemical Development

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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• Aides and may coordinate activity in the technology transfer (chemical process, analytical methods, and specifications) and development and manufacturing activities with Neurocrine partner companies for pre-clinical, clinical or commercial raw materials, intermediates, regulatory starting materials and/or API production or development

• Coordinates project meetings for the NBI-CMO and CMC internal project team, captures minutes and updates the team and leadership on progress and timelines

• May sit on multiple programs and manage project timelines to ensure timely delivery on goals, identify potential issues or threats, escalate problems as necessary

• Represents CMC in cross-functional development teams internally and externally to effectively meet science and business-critical objectives and timelines

• Liaison with Production and Regulatory in support of technology transfer of processes from development to regular production, in compliance with applicable regulatory guidelines (i.e. CMC, cGMP)

• Provide support through all facets of process development from small scale synthesis to scale-up manufacturing

• May create manufacturing protocols, reports, and batch records

• Support and may lead quality audits and Defense in Depth activities when deemed appropriate

• Provides logistical and scientific oversight support of process development both for API projects including projects of limited scope, such as solid-state form and catalytic process screening as well as new technology endeavors as deemed of interest

• Assigned to a contract manufacturing sites, acting as person-at-plant under general guidance, to monitor and ensure contractual obligations are met, escalating issues as needed

• Creates CRO/CMO partner relationships and collaborate with Chemical Development leadership to identify and select potential API development and/or manufacturing partners

• Partners and provides support to multiple functional lines (Pre-clinical, Clinical, CMC, Regulatory, Quality Assurance, Commercial) within the company

• Coordinates and may co-lead meetings with NBI personnel, as needed, to ensure cross-functional participation on the technology transfer teams and capture minutes and manage timelines

• Uses the CMO/CRO information/metrics to track progress outside of Neurocrine for application to new projects

• General knowledge of business relationship principles and theories and possesses intellectual mastery of one or more areas (tech-transfer, contracts, budget, Legal, Quality, Regulatory)

• Other duties as assigned

• BA/BS in a scientific discipline and 2+ years experience in supporting the development and manufacture of API's, cross-functional teams, vendor selection and supply chain strategies, raw material sourcing, and familiarity with regulatory filing expectations documents

• Some experience with working / recommending a variety of management techniques for contracting with external partners (FTE, cost-basis, staged deliverables, etc.)

• 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 and ability to coordinate multiple deliverables

• Capable to serve as internal lead for externally resourced programs

• Knowledge in scientific discipline and understands the scientific method

• General knowledge of Pharmaceutical CMC related process chemistry, solid state material properties/manipulations and analytical techniques necessary to develop and manufacture API

• General knowledge of Pharmaceutical CMC activities related to API, Drug Product, Analytical and Clinical Trial Material functions

• Knowledge of regulatory and quality aspects of CMC and API activities and documentation

• Ability to think creatively and be a team player

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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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