Director, CMC Supplier Management

🕒 Junho 20

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Cristcot

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2008

🏥 Saúde

🏭 Manufatura

💊 Farmacêutico

💰 $10.473.043 Venture Round - Cristcot em 2025-06

Healthcare • Manufacturing • Pharmaceuticals

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

• Manage and oversee the relationship with suppliers including production schedules, equipment readiness, and line performance metrics while ensuring coordination and logistics for finished products • Identify and onboard new suppliers as needed, then build the relationships with the same while ensuring adherence to quality, timely delivery, and cost objectives • Develop supplier evaluation criteria, RFP content, technical due diligence materials, and vendor comparison summaries for prospective suppliers • Monitor supplier performance and conduct regular business and technical reviews including person-in-plant activities • Lead technology transfer of pharmaceutical and combination product processes from development to manufacturing including readiness, transfer package, risk management, and validation support • Support execution across the external supplier network including development campaigns, validation activities, manufacturing readiness, supply continuity, and resolution of manufacturing or technical issues • Ensure compliance with GMP, FDA, ISO, and company quality standards in all drug product and drug substance related operations • Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for overall assembly and packaging • Work closely with Engineering, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, and launches • Provide CMC technical input to Quality owned documentation and records including batch records, deviation reports, CAPAs, and change controls • Support audits and inspections by regulatory authorities and partners

🎯 Requisitos

• Master’s degree in a Science related field, such as Pharmaceutics, Life Sciences, or related scientific field • Ph.D. degree in scientific discipline preferred • 10+ years of experience in pharmaceutical or combination product manufacturing • Strong knowledge of pharmaceutical regulations: FDA 21 CFR Part 820, FDA Guidance Documents, and pharmaceutical GMP standards • Proven ability to lead cross-functional teams and manage supplier relationships • Preferred experience in topical products, i.e. creams, lotions, suppositories, etc. • Experience with combination product design controls • Familiarity with electronic documentation systems (e.g., MES, eQMS, etc.) • Six Sigma, Lean, or PMP certification preferred • Ability to travel 20-25%.

🏖️ Benefícios

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development