Director, CMC External Manufacturing

Vaga não está no LinkedIn

🕒 Novembro 4

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $210.000 - $235.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Lead the strategy, selection, and management of CDMOs for drug substance and drug product manufacturing • Serve as the primary operational interface between Praxis and external manufacturing partners • Oversee technology transfer, process scale-up, validation, and clinical supply readiness • Establish and maintain Quality and Technical Agreements with manufacturing partners • Manage the end-to-end supply chain, including raw materials procurement, production planning, logistics, inventory management, and distribution • Lead supplier qualification, monitoring, and performance evaluations • Address supplier risks and identify improvement opportunities • Negotiate contracts and pricing agreements with suppliers and CMOs • Collaborate with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams on CMC deliverables • Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives • Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply • Ensure outsourced manufacturing meets GMP and regulatory standards • Implement KPIs and governance mechanisms to monitor and improve CDMO performance • Identify and mitigate technical and operational risks across the external supply network • Drive operational excellence and process improvements to enhance efficiency and compliance

🎯 Requisitos

• Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered • 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry • At least 8 years managing external manufacturing relationships • 10+ years of small molecule experience • Experience managing global CMC supply chains for commercial products in a regulated environment • Strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting • Experience overseeing both drug substance and drug product manufacturing at clinical and/or commercial scale • Experience negotiating with vendors and managing CMOs and third-party relationships • Ability to manage complex projects and external relationships with technical and business acumen • Ability to navigate complex regulatory and compliance requirements

🏖️ Benefícios

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) matching up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns

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