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)
At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
About the Role:
Responsible for providing operational leadership for packaging activities and external contract packaging partners to support reliable product supply and program execution. Serves as a subject matter expert, applying advanced packaging and supplier management expertise to lead complex initiatives, assess and mitigate risk, optimize external partner performance, and ensure quality, cost, compliance, and delivery objectives are achieved. Works independently and cross-functionally to influence decisions, resolve complex challenges, and develop scalable packaging and supplier strategies that support evolving business needs. Responsible for the strategy, implementation, and management of serialization activities.
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Your Contributions (include, but are not limited to):
- Leads cross-functional collaboration with internal stakeholders and contract packaging partners to establish packaging requirements, anticipate and mitigate complex risks, ensure regulatory compliance, and drive successful execution of packaging strategies and plans
- Provides functional expertise and strategic direction in assessing contract packager capabilities and capacity, identifying gaps and driving solutions to support reliable, scalable, and predictable delivery of products and programs
- Independently identifies, evaluates, and leads process improvements and solutions to complex packaging and operational challenges, influencing internal and external stakeholders to drive sustainable outcomes
- Develop and implement serialization requirements for new products and ensure compliance with DSCSA regulations
- Serves as a key subject matter expert and point of contact for contract packaging activities, providing strategic and operational visibility to stakeholders and aligning competing priorities across programs and business needs
- Leads oversight of complex contract packaging operations, including schedules, timelines, costs, performance metrics, quality, and delivery objectives; proactively identifies, assesses, and mitigates operational and supply risks
- Develops, implements, and continuously improves supplier selection, governance, and performance management processes, including scorecards and key performance indicators, to ensure appropriate oversight, accountability, and supplier performance
- Provides expertise and cross-functional leadership in the development, evaluation, and negotiation of RFQs, RFPs, Statements of Work, and Supply Agreements for existing and prospective contract packaging partners
- Partners with Logistics and Trade Compliance to establish effective approaches for inbound and outbound product and material movement, proactively addressing complex shipment or supply continuity issues
- Partners with Quality Assurance and contract packaging organizations to ensure ongoing compliance with cGMP requirements, Neurocrine procedures, and applicable quality systems, including change control; provides guidance and drives resolution of complex compliance-related issues
- Applies extensive packaging and external manufacturing expertise to influence functional strategies, improve external partner performance, and support the continued growth and scalability of packaging operations
- Other duties as assigned
Requirements:
- BS/BA degree AND 8+ years of direct and proven packaging experience in the pharmaceutical industry, including project management, packaging validation and commercial scale production OR
- Masters AND 6+ years of related experience OR
- PhD AND 4+ years of related experience and previous managerial / functional management experience
- Must have Small Molecule experience
- Experience with Serialization management platforms, e.g. TraceLink
- Demonstrated expertise in planning and leading complex projects and initiatives, including managing priorities, resources, dependencies, risks, and cross-functional collaboration across Development, Quality, CMC, and other relevant functions
- Demonstrated experience managing external partners, contracts, budgets, and supplier performance, with the ability to balance operational, financial, quality, and business considerations
- Strong knowledge of pharmaceutical/biotechnology packaging operations and their interdependencies with product supply, external manufacturing, finance, logistics, and broader supply chain operations
- Demonstrated ability to provide subject matter expertise and influence decisions related to packaging strategy, external partner capabilities, operational execution, and supply continuity
- Strong understanding of cGMP requirements and applicable quality systems, with demonstrated ability to identify compliance risks and partner effectively with Quality and external organizations to drive resolution
- Demonstrated ability to assess complex operational and supplier-related risks, develop mitigation strategies, and make sound recommendations in situations where established approaches may not fully address the issue
- Ability to translate business and program requirements into actionable packaging and supplier strategies that support current needs and future operational scalability
- Excellent written, verbal, interpersonal, and presentation skills, with the ability to communicate technical and business considerations effectively to both internal and external stakeholders
- Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices pertaining to primary and secondary packaging
- Applies advanced knowledge of their discipline and a strong understanding of related functions to address complex business needs, improve processes, and deliver high-quality outcomes with broad cross-functional impact
- Independently identifies, evaluates, and resolves complex technical, operational, and organizational challenges where solutions may require significant judgment and consideration of multiple factors
- Serves as a subject matter expert and frequently represents the function on cross-functional initiatives, providing expertise, recommendations, and guidance to influence decisions and outcomes
- Demonstrates strong ability to influence and align stakeholders across functions and levels in a matrixed environment, including situations involving competing priorities or differing perspectives
- Applies advanced analytical, critical thinking, and creative problem-solving skills to evaluate complex issues, assess risk, and develop effective solutions
- Communicates complex information, recommendations, and strategies clearly and effectively to stakeholders at varying levels of the organization through strong written, verbal, interpersonal, and presentation skills
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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 $143,600.00-$196,000.00. 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 30% 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.