Director, CMC External Manufacturing

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $210k - $235k / year

⏰ Full Time

🔴 Lead

👔 Director

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Lead and manage outsourced manufacturing operations supporting clinical and future commercial programs • 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 end-to-end supply chain activities, including raw materials procurement, production planning, logistics, inventory management, and distribution • Lead supplier qualification, monitoring, and performance evaluations • Negotiate supplier and CMO contracts and pricing agreements • 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 complies with 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

🎯 Requirements

• 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 • 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 • Excellent negotiation and vendor management abilities, including experience working with CMOs and managing third-party relationships • Ability to manage complex projects and external relationships with technical and business acumen • Ability to navigate complex regulatory and compliance requirements • Flexibility and willingness to travel as needed

🏖️ Benefits

• 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) match 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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