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

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Cristcot

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2008

🏥 Santé

🏭 Fabrication

💊 Pharmaceutique

💰 €10 473 043 Venture Round - Cristcot en 2025-06

Healthcare • Manufacturing • Pharmaceuticals

Cristcot est une entreprise de développement et de recherche pharmaceutique spécialisée dans les formulations de médicaments innovantes et les technologies combinées médicament-dispositif discrètes conçues pour améliorer l'observance des patients, réduire la charge thérapeutique et intégrer les thérapies dans la vie quotidienne. Fondée en 2008 et basée à Austin, Texas, Cristcot fournit la conception et l'exécution de recherches cliniques, l'ingénierie de formulations et de modes d'administration novateurs, le développement de dosages spécialisés, et le soutien à la stratégie réglementaire ; sa principale thérapie expérimentale a achevé une étude pivot de Phase 3. L'entreprise se concentre sur la résolution des obstacles souvent négligés dans la gestion des maladies en créant des solutions intuitives et économiques permettant des soins plus efficaces et plus sûrs.

Description

• 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.

🎯 Exigences

• 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%.

🏖️ Avantages

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