Principal Specialist, Pharmaceutical Ops (Remote)

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, but few options.What We Do:Neurocrine Biosciences is a 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, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVieAbout the Role:Support activities related to Clinical Trial Material (Phase 1-4); providing support to the Director, Clinical Supplies, cooperate with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Responsible for supporting and/or managing complex studies requiring Clinical Supplies project management, forecasting, IXRS, distribution, and supply logistics such as packaging/labeling and global distribution. This position will interface with Clinical, Project Management, Regulatory, QA, Manufacturing and teams. The Senior Specialist, Clinical Supplies will work with vendors involved in the planning, distribution, storage and destruction of Clinical trial supplies for Clinical investigational sites as required._Your Contributions (include, but not limited to):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 requiredPlan and design packaging configurations to support clinical protocols as neededReview 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 requirementsEstablish distribution requirements and set up distribution plans and contracts with appropriate partiesEstablish IRT requirement and manage CTM supply within the IRT throughout a clinical studyManage 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 processesCreate, review and approve all required documentation for engaging CMOs, including budget review, contract review, scheduling, manufacturing, packaging, labeling & testing of drug products at CMO sitesDevelop and support all SOPs required to perform required tasks per cGMP standards and Neurocrine expectationsAs 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 timelinesProvide operational support services to the CMC Development and Commercial Supply Chain/Manufacturing functions to include management of Stability Packaging operations.Other duties as assignedRequirements: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 ORMaster’s in supply chain, operations management or science-related field preferred and 6+ years of similar experience noted aboveGood knowledge of formulation and manufacture of small molecules for use in the pharmaceutical industryMust have demonstrated capabilities in Drug Product Manufacturing activities, project management, planning, budgeting, managing third party vendors and timely goal achievementThorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directivesProficiency in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systemsStrong 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 reviewStrong understanding of distribution practices including cold chainUnderstand managing blinded clinical studies and what is required to protect that blindGrounded in the fundamentals of pharmaceutical development with advanced packaging and labeling technical knowledge along with an understanding of Regulatory, Manufacturing and Analytical interactions and requirementsMust 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 forecastingHas knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplinesWorks to improve tools and processes within functional areaDeveloping reputation inside the company as it relates to area of expertiseAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skills, with proficiency in Microsoft applicationsExcellent communications, problem-solving, analytical thinking skillsSees broader picture, impact on multiple departments/divisionsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skillsEffective communication with technical personnel both internally and externallyAbility to establish and meet multiple concurrent priorities and deadlines#LI-DM1Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.SummaryLocation: US CA Home OfficeType: Full time