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Salary: USD 180,000 - 200,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related conditions including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company's lead candidate, lorundrostat, is a selective aldosterone synthase inhibitor.
The Senior Director of Commercial Manufacturing will lead the commercial manufacturing function, providing technical and organizational leadership for drug product and active pharmaceutical ingredient (API) manufacturing across all contract manufacturers. This role oversees scale-up, validation, launch, and continued supply of commercial products and samples.
Key responsibilities include:
- Heading the Commercial Manufacturing function and ensuring on-time, on-budget delivery to meet forecasted sales volumes
- Participating in Sales and Operations Planning to review actual sales and sample distribution, revising forecasts accordingly
- Providing forecast updates and monthly production/inventory reports to contract manufacturers and internal Finance teams
- Establishing and overseeing commercial manufacturing strategies aligned with company objectives
- Selecting and qualifying third-party suppliers for a 100% outsourced manufacturing model
- Preparing regulatory documentation for global filings and supporting Health Authority responses
- Serving as subject matter expert in drug product manufacturing, partnering with development functions and representing Commercial Manufacturing on the CMC team
- Ensuring compliance with GxP and global regulatory requirements in collaboration with Quality Assurance and Regulatory Affairs
- Managing budget, schedules, and performance metrics
- Hiring, mentoring, and developing staff as the company grows
This is a fully remote position requiring up to 50% travel, including frequent overnight trips.
Requirements:
- Advanced degree in pharmaceutical sciences, engineering, or related discipline (PhD highly preferred)
- Minimum 15 years' industry experience in cGMP drug product manufacturing, specifically small molecule dosage forms; NDA experience required
- Minimum 10 years' industry experience in cGMP small molecule API manufacturing (ideal)
- Strong knowledge of US and EU cGMP requirements, ICH guidelines, and best practices for drug products and APIs
- Strong knowledge of formulation development and drug product manufacture across all development phases from initial regulatory filings through registration, scale-up, validation, launch, and commercial supply
