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San Diego, California, United States
Onsite
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)
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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
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 thinking skills
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management skills
Demonstrated success in project planning, resource management, and collaboration with Development, Quality, Regulatory, and CMC
Expertise in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices
Strong knowledge of biotech/pharma manufacturing operations, and product and process development
Familiarity with document management platforms, e.g. Veeva
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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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The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.