Director, Commercial Manufacturing

Role Summary

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.

Responsibilities

• 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

• BS/MS in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field.
• 8-10 years of progressive experience in pharmaceutical small molecule manufacturing or technical operations, with 5+ years in a leadership or managerial role, ideally with direct experience managing contract manufacturing organizations (CMOs).
• Strong background in GMP environments, commercial supply chain planning, process optimization, and cross-functional collaboration (e.g., with Quality, Regulatory, and Finance)
• Experience with tech transfer, scale-up, and lifecycle management of commercial small molecule pharmaceutical products including API chemical synthesis, drug product manufacturing, and packaging.
• Demonstrated ability to work collaboratively and effectively with cross-functional groups.
• Working knowledge of global GMP regulations and CMC content of regulatory submissions, with a focus on FDA and EMA/MHRA.
• Strong verbal and written communication with solid organizational, time management, and project management skills.
• Displays sense of urgency to resolve problems that arise during manufacturing.
• Ability to develop solutions to complex problems and influence resolution both internally and externally.

Skills

• CMC strategy development and execution
• CMC documentation review (batch records, DS/DP data, analytical methods)
• CMO relationship management
• Budgeting and cost modeling for manufacturing campaigns
• Regulatory submissions support (FDA/EMA/MHRA)
• Cross-functional collaboration and program management

Education

• BS/MS in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field