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, but few options.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Primary contact with assigned drug product CMOs

• Leads Business Review Meetings at assigned CMOs

• Collaborates with internal cross-functional teams and drug product CMOs to determine commercial manufacturing requirements, identify and mitigate key risks, and ensure that manufacturing plans are executed as intended

• Maintains a database to monitor and analyze manufacturing parameters at CMOs

• Drives on-time and predictable delivery of products and projects at assigned CMOs

• Reviews pre- and post-production documents (e.g., master and executed batch records, change controls, protocols, technical reports), and manages the approval process for the same

• Leads the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, and delivery metrics, and program objectives, are met

• Provides occasional Person-in-Plant coverage at assigned CMOs for critical production activities as/when needed

• Participates in the identification, analysis and resolution of complex issues at CMOs that could impact the cost, quality, and delivery of product

• Leads the supplier management processes including relevant scorecards, to ensure appropriate controls, oversight, monitoring, and remediation are in place

• Collaborates with the CMC team on the identification and selection of CMO sites for pipeline programs advancing to commercialization

• Participates in the preparation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements

• Supports validation activities at assigned CMOs as/when needed

• Collaborates with the Commercial Manufacturing team and Quality Assurance to ensure CMOs are compliant with all cGMP guidelines and Company SOP requirements

• Collaborates with Supply Chain Planning and Logistics to ensure timely and reliable product supply to patient

• Supports the optimization of spend at the CMOs, performs post batch release data entry to ensure timely payment to CMOs

• Other duties as assigned

• BS/BA degree in Engineering, Science or related field and 4+ years of Project Management and Drug Product Manufacturing, Process Development experience in the Pharmaceutical industry. Direct successful experience of managing relationship with (or from) CMO is essential. Experience with manufacture of solid oral dosage products, with an emphasis on drug product operations. Direct experience with the manufacture of marketed products. Experience working in a cGMP-regulated environment, including knowledge of relevant US / EU regulatory and quality requirements, standards and practices. Familiarity with and knowledge of large molecule formulation is preferred OR

• Master's degree in Engineering, Science, or related field and 2+ years of similar experience noted above

• Has experience of being a lead, ideally primary, contact from CMO or sponsor side for cGMP manufacture of drug product

• Strong project management skills

• Understands key business drivers and uses this understanding to accomplish work

• Has a good understanding of pharmaceutical processes, GMP procedures, and systems used to accomplish the work and recognizes downstream impact on other functional areas

• Proficient with tools and processes that support work conducted by functional areas

• Ability to work as part of a team

• Excellent computer skills

• Strong communications, problem-solving, analytical thinking skills

• Detail-oriented yet can see broader strategic picture for department

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

• Working knowledge of cGMP-regulations, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices

• Familiarity with document management platforms, e.g. Veeva

• Familiarity with and knowledge of large molecule processing is preferred

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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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