Clinical Supply Chain Manager

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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• Lead CTM supply chain activities starting with collaborating with Clinical Operations to forecast all required products per clinical study including Investigational Products (IP), ancillary components and comparators/background medications that are required

• Plan and design packaging configurations to support clinical protocols as needed

• Review and approve all required documentation for CTM packaging. This will include label generation, translations management, component specifications, bottling, blistering, kitting at a minimum. Work collaboratively with internal departments to produce products meeting appropriate requirements

• Establish distribution requirements and set up distribution plans and contracts with appropriate parties

• Establish IRT requirement and manage CTM supply within the IRT throughout a clinical study

• Manage vendors, including to identify, evaluate and ensure outsourced vendors have the required expertise, capabilities and quality/compliance standards to support drug product manufacturing, packaging, labeling, distribution, storage and destruction processes

• Create, review and approve all required documentation for engaging CMOs, including budget review, contract review, scheduling, manufacturing, packaging, labeling & testing of drug products at CMO sites

• Develop and support all SOPs required to perform required tasks per cGMP standards and Neurocrine expectations

• As a project member or leader, may represent Pharmaceutical Operations in Company-CMO project team meetings. Inform Pharmaceutical Operations leaders as well stakeholders as to progress, resource requirements, barriers/issues needing resolution and timelines

• Provide operational support services to the CMC Development and Commercial Supply Chain/Manufacturing functions to include management of Stability Packaging operations

• Other duties as assigned

• BS/BA degree in supply chain, operations management or science related field and 8+ years of clinical supply chain management experience; Experience IRT/IXRS/IWVR required. Experienced in building and managing forecasts for clinical supply chains. Experience with cGMPs, GCPs, and other regulatory requirements OR

• Master's in supply chain, operations management or science-related field preferred and 6+ years of similar experience noted above

• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

• Works to improve tools and processes within functional area

• Developing reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent computer skills, with proficiency in Microsoft applications

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management skills

• Effective communication with technical personnel both internally and externally

• Ability to establish and meet multiple concurrent priorities and deadlines

• Good knowledge of formulation and manufacture of small and large molecules for use in the pharmaceutical industry

• Must have demonstrated capabilities in Drug Product Manufacturing activities, project management, planning, budgeting, managing third party vendors and timely goal achievement

• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives

• Proficiency in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systems

• Strong working knowledge of FDA clinical trial material requirements for IND's and NDA's as well as European regulatory requirements for dossier filing input and review

• Strong understanding of distribution practices including cold chain

• Understand managing blinded clinical studies and what is required to protect that blind

• Grounded in the fundamentals of pharmaceutical development with advanced packaging and labeling technical knowledge along with an understanding of Regulatory, Manufacturing and Analytical interactions and requirements

• Must have demonstrated strong capabilities in project management across multiple projects with a full understanding of packaging, labeling and distribution requirements. Must have Clinical Protocol interpretation background to support demand forecasting

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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 don't line up to exactly what we have outlined in the job description.

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