Senior Manager/Associate Director/Director, Packaging & Labeling Operations

🕒 Junho 20

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Cristcot

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2008

💊 Farmacêutico

🔬 Ciência

💰 $10.473.043 Venture Round - Cristcot em 2025-06

Pharmaceuticals • Science

Cristcot é uma empresa de desenvolvimento e pesquisa farmacêutica especializada em formulações de medicamentos inovadores e tecnologias de combinação de dispositivos medicamentosos discretas projetadas para melhorar a adesão do paciente, reduzir a carga do tratamento e integrar terapias no dia a dia. Fundada em 2008 e sediada em Austin, Texas, a Cristcot oferece design e execução de pesquisa clínica, engenharia de formulações e administração inovadoras, desenvolvimento de ensaios especializados e suporte à estratégia regulatória; sua principal terapia investigacional concluiu um estudo fundamental de Fase 3. A empresa foca em solucionar barreiras negligenciadas no gerenciamento de doenças, criando soluções intuitivas e econômicas que possibilitam um cuidado mais eficaz e confiante.

Descrição

• Provide strategic and operational oversight of packaging and labeling activities. • Manage internal and external stakeholders. • Drive continuous improvement initiatives across the product lifecycle. • Lead packaging and labeling operations to support clinical, commercial, and post-market activities. • Lead packaging validation, shipping validation, and drop test strategy and execution oversight. • Ensure packaging and labeling processes comply with applicable FDA, ISO, MDR, and other global regulatory requirements. • Own sponsor side technical oversight for primary packaging, labeling, artwork, printed packaging components, and commercial kitting of drug product and device components. • Develop and maintain approval, implementation, and control of packaging and labeling specifications, procedures, and documentation. • Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Product Development teams to ensure alignment across product lifecycle activities. • Support product launches, design changes, market expansions, and supply continuity initiatives. • Provide sponsor side oversight of serialization readiness and execution at CMO. • Manage packaging, labeling, kitting, and serialization related vendors, including governance, issue resolution, timelines, and technical deliverables. • Ensure packaging and labeling activities are performed in accordance with established quality systems and applicable regulations. • Investigate deviations, nonconformances, CAPAs, and labeling-related quality events. • Assess and mitigate operational and compliance risks associated with packaging and labeling activities. • Lead cross-functional projects related to packaging optimization, labeling implementation, product launches, and process improvements. • Develop and monitor key performance indicators (KPIs) for packaging and labeling operations. • Establish priorities, allocate resources, and ensure timely execution of operational objectives.

🎯 Requisitos

• Bachelor’s degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or related field required. • Advanced degree (MS, MBA, or equivalent) preferred. • Senior Manager: 8+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated healthcare industries with 3+ years of direct experience managing packaging and/or labeling operations. • Associate Director: 10+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated healthcare industries with 5+ years of leadership experience in packaging, labeling, manufacturing operations, supply chain, or related functions. • Director: 12+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated healthcare industries with 7+ years of progressive leadership experience, including responsibility for teams, budgets, and strategic initiatives. • Experience with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendors. • Experience working within FDA-regulated and/or ISO 13485 environments. • Strong knowledge of cGMP, packaging validation, shipping validation, labeling controls, artwork processes, and DSCSA governance. • Demonstrated experience leading cross-functional projects and managing external vendors or contract manufacturers. • Strong understanding of quality systems, document control, change management, and regulatory compliance. • Experience interacting with executive leadership, regulatory agencies, and external partners. • Experience supporting late stage or commercial product launch preferred. • Experience with combination products or medical devices preferred. • Experience with ERP, PLM, document management, and quality management systems. • Excellent project management and organizational skills. • Strong analytical and problem-solving capabilities. • Ability to work effectively in a fast-paced, growth-oriented environment. • Demonstrated leadership, collaboration, and stakeholder management skills. • Ability to travel 20-25%.

🏖️ Benefícios

• Health insurance • 401(k) • Paid time off • Flexible working arrangements • Professional development opportunities