Senior Director, Commercial Manufacturing

Role: Senior Director of Commercial Manufacturing overseeing the scale-up, validation, and supply of drug products and APIs for Mineralys' small molecule therapeutics, including lorundrostat. Responsibilities: lead manufacturing operations at outsourced facilities, manage production forecasts, coordinate with sales, develop strategies aligned with company goals, select and qualify third-party suppliers, ensure regulatory compliance, prepare documentation for filings, and support responses to health authorities. Requirements: PhD or advanced degree in pharmaceutical sciences or engineering; at least 15 years of industry experience in cGMP manufacturing of small molecule drug products, including NDA experience; minimum of 10 years in small molecule API manufacturing; strong knowledge of US/EU cGMP, ICH guidelines, and formulation development across all development phases. High-value: small molecule therapeutics, oral dosage forms, cGMP API and drug product manufacturing, NDA process, global regulatory compliance. Work setup: fully remote; travel up to 50%, often overnight and outside local area.