Senior Director, Commercial Supply Chain

The role

The Senior Director Commercial Manufacturing provides technical and organizational leadership and oversight of commercial drug product and API manufacturing activities at contract manufacturers. This role supports scale-up, validation, launch, and continued supply of commercial products and samples.

What you will do

• Head the Commercial Manufacturing function.
• Manufactures drug products and API on-time and on-budget to meet forecasted sales volumes.
• Participates on the Mineralys Sales and Operations Planning Team to review actual sales/sample distribution and revises drug product and API forecasts accordingly.
• Provides forecast updates to all CMOs in accordance with contract requirements.
• Provides monthly production and inventory reports from all CMOs to Mineralys Finance for monthly close.
• Establishes and oversees commercial manufacturing strategies and operational plans.
• Participates in the selection and qualification of third-party suppliers for commercial manufacturing.
• Oversees commercial manufacturing operations at third party service providers in a 100% outsourced business model.
• Prepares supporting documentation for global regulatory filings and provides technical support for responses to Health Authority comments and inquiries.
• Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.

Required qualifications

• Advanced degree in pharmaceutical sciences, engineering, or related discipline.
• 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.
• 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 c

Nice to have

• PhD highly preferred.
• Minimum of 10 years industry experience in manufacturing small molecule API according to cGMP regulations.

Benefits

• medical
• dental
• vision
• time off
• 401K
• participating in Mineralys incentive plans contingent on achievement of personal and company performance

About the company

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. It is headquartered in Radnor, Pennsylvania.