Director, CMC External Manufacturing

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and direct outsourced manufacturing operations that support clinical and future commercial initiatives.

• Develop the strategy, selection, and management of Contract Development and Manufacturing Organizations (CDMOs) for both drug substance and drug product manufacturing.

• Act as the main operational liaison between Praxis and external manufacturing partners.

• Supervise technology transfer, process scale-up, validation, and readiness for clinical supply.

• Establish and uphold Quality and Technical Agreements with manufacturing collaborators.

• Manage comprehensive supply chain operations, encompassing raw material procurement, production scheduling, logistics, inventory oversight, and distribution.

• Lead the qualification of suppliers, their monitoring, and performance assessments.

• Negotiate contracts and pricing agreements with suppliers and CMOs.

• Collaborate with teams in Process Chemistry, Formulation, Analytical, Quality, and Regulatory sectors on CMC deliverables.

• Support CMC development strategies that align with clinical timelines, regulatory requirements, and organizational goals.

• Oversee manufacturing planning, scheduling, and inventory management to guarantee an uninterrupted clinical supply.

• Ensure that outsourced manufacturing adheres to Good Manufacturing Practices (GMP) and regulatory standards.

• Implement Key Performance Indicators (KPIs) and governance frameworks to evaluate and enhance CDMO performance.

• Identify and mitigate technical and operational risks within the external supply network.

• Promote operational excellence and process enhancements to improve efficiency and compliance.

⛳️ Requirements

• An advanced degree is preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; a bachelor’s degree with substantial relevant experience will also be considered.

• Over 15 years of progressive CMC or manufacturing experience in the biopharmaceutical sector.

• A minimum of 8 years in managing relationships with external manufacturing partners.

• Experience in managing global CMC supply chains for commercial products within a regulated environment.

• Strong knowledge of GMP, GDP, and ICH guidelines and their implementation in a commercial context.

• Experience supervising both drug substance and drug product manufacturing at clinical and/or commercial scales.

• Exceptional negotiation and vendor management skills, including experience working with CMOs and overseeing third-party relationships.

• Capacity to manage complex projects and external relationships with both technical and business insight.

• Ability to navigate intricate regulatory and compliance frameworks.

• Willingness to travel as necessary.

🏝️ Benefits

• Coverage of 99% of the premium for medical, dental, and vision plans.

• Company-sponsored life insurance.

• Accidental Death & Dismemberment (AD&D) benefits.

• Disability benefits.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous Paid Time Off (PTO).

• Paid holidays.

• Company-wide shutdowns.