Senior Director, Commercial Manufacturing
Mineralys Therapeutics
Mineralys Therapeutics seeks a Senior Director of Commercial Manufacturing to lead drug product and API manufacturing operations across contract manufacturers. The role requires providing technical leadership, project oversight, and strategic planning to support product scale-up, validation, and commercial launch of its aldosterone synthase inhibitor candidate.
Responsibilities
- Lead commercial manufacturing function and oversee all contract manufacturing operations
- Develop manufacturing forecasts and participate in sales and operations planning
- Establish commercial manufacturing strategies aligned with company objectives
- Manage supplier selection, qualification, and oversight for manufacturing partners
- Prepare regulatory documentation and provide technical support for health authority submissions
Requirements
- Advanced degree in pharmaceutical sciences, engineering, or related field; PhD preferred
- Minimum 15 years in cGMP small molecule drug product manufacturing with NDA experience
- Minimum 10 years in cGMP small molecule API manufacturing
- Strong knowledge of US and EU cGMP requirements and ICH guidelines
- Experience in formulation development across all phases from regulatory filing through commercial supply
- Expertise in 100% outsourced manufacturing model with contract manufacturers
Vacancy posted 6 days ago
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