Who We Are:
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. _
Your Contributions (include, but are not limited to):
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/when needed
Analyzes, identifies and recommends process improvement, and solutions to complex issues at the CPOs
Partners with Quality Assurance to ensure CPOs are compliant with all cGMP guidelines and company SOP requirements
Other duties as assigned
Requirements:
Bachelor's Degree in Packaging, Mechanical, or Materials Engineering or related field and 4+ years of experience in the pharmaceutical development, or technical operations and product quality, focusing on packaging engineering development. Experience in the Biologics and/or parenteral drug product field is a plus OR
Master's Degree or higher in Packaging, Mechanical, or Materials Engineering or related field and 2+ years of experience as shown above
Experience with Serialization management platforms, e.g. TraceLink
Understands key business drivers and uses this understanding to accomplish work
Proficient with tools and processes that support work conducted by functional areas
Ability to work as part of a team
Excellent computer skills
Strong communication, problem-solving, analytical…