Senior Director, Commercial Manufacturing

Mineralystherapeutics; United States; Remote; USD 180,000 - 200,000; Full time

Job summary

Mineralys Therapeutics, a fully remote biopharmaceutical company in the United States, seeks a Senior Director Commercial Manufacturing to lead all contract manufacturing activities for commercial drug products and APIs. The role drives scale-up, validation, launch readiness, and ongoing supply across CMOs while aligning with company strategy.

The candidate will oversee forecasting, supplier qualification, and regulatory support, collaborating with QA and Regulatory to meet GxP standards.

Qualifications

• PhD (preferred) in pharmaceutical sciences or related field.
• Minimum 15 years’ industry experience in cGMP drug product manufacturing.
• Ideal: ≥10 years API manufacturing experience under cGMP.
• Strong knowledge of US/EU cGMP and ICH guidelines.

Responsibilities

• Head the Commercial Manufacturing function and oversee CMOs.
• Ensure on-time, on-budget drug product and API manufacture to forecast.
• Provide forecasts and monthly production/inventory reports.
• Collaborate with QA and Regulatory to ensure GxP compliance.
• Mentor staff and align work with company objectives.
• Support global regulatory filings and Health Authority inquiries.

Skills

cGMP knowledge

NDA experience

leadership

project management

cross-functional collaboration

Education

PhD in pharmaceutical sciences or related

Job description

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys onLinkedIn,TwitterandBluesky

Mineralys is a fully remote company.

Position Summary

The Senior Director Commercial Manufacturing will be responsible for providing technical and organizational leadership, project management and oversight of commercial drug product and API manufacturing activities at all contract manufacturers to support scale-up, validation, launch, and continued supply of commercial products and samples needed by the commercial organization.

Key Responsibilities

1. Head the Commercial Manufacturing function.
2. Manufactures drug products and API on-time and on-budget to meet forecasted sales volumes.
3. Participates on the Mineralys Sales and Operations Planning Team to review actual sales/sample distribution and revises drug product and API forecasts accordingly.
4. Provides forecast updates to all CMOs in accordance with contract requirements.
5. Provides monthly production and inventory reports from all CMOs to Mineralys Finance for monthly close.
6. Establishes and oversees commercial manufacturing strategies and operational plans across a portfolio of projects and ensures that they are aligned with the strategic and operational objectives of other functions, and of the company.
7. Participates in the selection and qualification of third-party suppliers for commercial manufacturing.
8. Oversees commercial manufacturing operations at third party service providers in a 100% outsourced business model.
9. Prepares supporting documentation for global regulatory filings and provides technical support for responses to Health Authority comments and inquiries to support commercial marketing applications.
10. As a subject matter expert (SME) in Drug Product Manufacturing, be a key partner to the Drug Substance, Drug Product, and Analytical Development functions and represent the Commercial Manufacturing function on the CMC Team.
11. Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
12. Ensure budget, schedules, and performance requirements are met.
13. May hire, mentor, and develop staff according to the future needs of a growing company.

Education & Experience

• Advanced degree in pharmaceutical sciences, engineering, or related discipline. PhD highly preferred.
• A minimum of 15 years’ industry experience in cGMP drug product manufacturing, specifically in the development and manufacturing of small molecule dosage forms; NDA experience required.
• Ideal candidate will also have a minimum of 10 years’ industry experience in manufacturing small molecule API according to cGMP regulations.
• Strong knowledge of US and EU cGMP requirements, ICH guidelines and best practices relating to drug products and API.
• Strong knowledge of formulation development and drug product manufacture across all phases of drug development from initial regulatory filings through registration, scale-up, validation, launch, and commercial supply.

Travel

• This position requires up to 50% travel. Frequently travel is outside the local area and overnight.

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range: $180,000-$200,000