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Role Overview:
- Lead the Commercial Manufacturing function at Mineralys.
- Oversee drug product and API manufacturing at contract manufacturers.
Key Responsibilities:
- Manage production forecasts, inventory reports, and CMO relationships.
- Support regulatory filings and ensure GxP compliance.
- Collaborate with Quality, Regulatory, and CMC teams.
Qualifications:
- 15+ years in cGMP small molecule drug product manufacturing.
- NDA experience and strong knowledge of US/EU cGMP and ICH guidelines.
Mineralys Therapeutics
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to target hypertension and related comorbidities. It is headquartered in Radnor, Pennsylvania and operates as a fully remote company.