Director, External Manufacturing – CMC

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November 26

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Praxis

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Biotechnology • Healthcare Insurance • Science

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.

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

📋 Description

• Lead and manage outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs. • Oversee Contract Development and Manufacturing Organizations (CDMOs) for drug substance (API) and drug product manufacturing. • Ensure high-quality, compliant, and timely supply of clinical materials. • 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 robust Quality and Technical Agreements with manufacturing partners. • Manage and optimize the end-to-end supply chain process. • Lead supplier qualification, monitoring, and performance evaluations. • Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes.

🎯 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, including ≥8 years managing external manufacturing relationships. • Proven experience in managing global CMC supply chains for commercial products in a regulated environment. • Demonstrated experience overseeing both drug substance and drug product manufacturing at clinical or commercial scale. • Excellent negotiation and vendor management abilities including experience working with CMOs and managing third-party relationships. • Proven ability to manage complex projects and external relationships with technical and business acumen. • Ability to navigate complex regulatory and compliance requirements.

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans. • Company-paid life insurance, AD&D, disability benefits, and voluntary plans. • Dollar-for-dollar match up to 6% on eligible 401(k) contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Flexible wellness benefit. • Generous PTO, paid holidays and company-wide shutdowns.