Director, Commercial Manufacturing

Zevra Therapeutics, Inc.

We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients.

About the role

The Director of Commercial Manufacturing will oversee external contract manufacturing organizations (CMOs) to ensure consistent, compliant, and cost-effective production of small-molecule pharmaceutical products. This role relies on close cross-functional collaboration with internal teams, including Commercial, Medical / Clinical, and Quality / Regulatory, to ensure a reliable high-quality supply of Zevra products as needed for patients.

What you'll do

• Select, manage and interface with CMOs to ensure drug substance, finished dosage form and related primary packaging operations are completed in compliance with cGMP requirements.
• Develop and maintain technical and business relationships with respective CMOs.
• Assist with development and execution of Supply / Service Agreements and Quality Agreements in coordination with Legal and Quality Assurance
• Provide product expertise to CMOs during manufacturing campaigns including assistance with troubleshooting.
• Engage in internal cross-functional collaboration across program teams to support supply.
• Manage product inventory levels by adjusting manufacturing plans at CMOs in response to evolving demand forecasts
• Coordinate and implement process optimization initiatives and long-term strategies for cost reduction and risk mitigation across supply chain and manufacturing operations.
• Identify manufacturing problems and initiate / coordinate manufacturing investigations with Quality Assurance. Review technical information for different manufacturing operations and assess deviations and impact.
• Develop and / or complete technical review of manufacturing documents (batch records, formulation / process data, analytical methods, protocols, reports, data).
• Direct and formulate CMC regulatory strategies and CMC sections of regulatory submissions and related information.
• Partner with Finance to provide budgets and cost models as needed of various products, as well as manufacturing campaign forecasts and work-in-process (WIP) cost reports.

Qualifications

Equal Employment Opportunity Statement

Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Notice to External Recruiters

Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.

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