Senior Engineer, Packaging

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the role

Provides operational support for the relationships and assigned activities of commercial Contract Packaging Organizations (CPOs) within the company's supply chain network. Actively participates in assigned cross-functional activities relating to commercial packaging at CPO sites. Contributes to activities related to the timely planning, scheduling, manufacturing, and quality control of production operations. Participate in technical discussions and technical review of packaging documentation. Responsible for the strategy, implementation, and management of serialization activities.

Responsibilities

• Collaborate with external Vendors, Supply Planning, Packaging Development and Logistics to ensure on-time and predictable delivery of products and projects at assigned CPOs
• Owns the supplier management process including scorecards and business review meetings to ensure appropriate controls, oversight and monitoring are in place
• Monitor and support TraceLink transaction processing, EPCIS data exchange activities and serialization data integrity
• Develop and implement serialization requirements for new products and ensure compliance with DSCSA regulations
• Reviews pre- and post-production documents and manages the approval process
• Collaborate with packaging development, quality, supply chain and regulatory to implement artwork and lifecycle changes at CPO for the commercial portfolio
• Supports deviation and product complaint root cause analysis and resolution with CPOs
• Supports validation activities at assigned CPOs
• Participates in the preparation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
• Provides Person-in-Plant coverage at assigned CPOs for critical production activities as