Senior Director, Commercial Supply Chain

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the Commercial Manufacturing department

• Offer technical and organizational guidance, project management, and oversight of commercial drug product and API production activities at contract manufacturers

• Assist in the scale-up, validation, launch, and ongoing supply of commercial products and samples

• Ensure timely and budget-compliant manufacturing of drug products and APIs to meet projected sales volumes

• Engage in Sales and Operations Planning to assess sales/sample distribution and adjust forecasts

• Deliver forecast updates to contract manufacturing organizations as stipulated in contracts

• Submit monthly production and inventory reports to Finance for monthly closing activities

• Develop and supervise commercial manufacturing strategies and operational plans across various projects

• Participate in the selection and qualification process of third-party suppliers

• Manage commercial manufacturing operations at third-party service providers within a fully outsourced business model

• Prepare necessary documentation for global regulatory submissions and provide technical assistance for Health Authority inquiries

• Act as a subject matter expert in Drug Product Manufacturing and represent Commercial Manufacturing on the CMC Team

• Work collaboratively with Quality Assurance and Regulatory Affairs to ensure adherence to GxP and global regulatory standards

• Guarantee that budgetary, scheduling, and performance objectives are fulfilled

• May recruit, mentor, and develop personnel based on future organizational needs

⛳️ Requirements

• Advanced degree in pharmaceutical sciences, engineering, or a closely related field

• PhD is highly preferred

• At least 15 years of industry experience in cGMP drug product manufacturing

• Experience in the development and manufacturing of small molecule dosage forms

• NDA experience is mandatory

• A minimum of 10 years of industry experience in manufacturing small molecule APIs in compliance with cGMP regulations is ideal

• Extensive knowledge of US and EU cGMP requirements, ICH guidelines, and best practices related to drug products and APIs

• In-depth understanding of formulation development and drug product manufacturing throughout all stages of drug development, from initial regulatory submissions to registration, scale-up, validation, launch, and commercial supply

• Willingness to travel up to 50%, often outside the local area and requiring overnight stays

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Time off

• 401K

• Participation in Mineralys incentive plans based on personal and company performance achievements