Senior Director, Commercial Manufacturing

Mineralys Therapeutics

5d•$180,000 - $200,000•Remote

About The Position

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. Mineralys is a fully remote company. 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.

Requirements

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.

Responsibilities

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 across a portfolio of projects and ensures that they are aligned with the strategic and operational objectives of other functions, and of the company.
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 to support commercial marketing applications.
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.
Collaborate with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements.
Ensure budget, schedules, and performance requirements are met.
May hire, mentor, and develop staff according to the future needs of a growing company.