Director, Commercial Manufacturing - Boston, MA
1 day ago
Job description
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
- 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.
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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