Senior Director, Commercial Supply Chain

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

📋 Description

• Lead the Commercial Manufacturing department.

• Deliver technical and organizational guidance, project management, and oversight of commercial drug product and API manufacturing 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 API to meet projected sales volumes.

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

• Provide forecast updates to contract manufacturing organizations in accordance with contract stipulations.

• Supply monthly production and inventory reports to Finance for the monthly closing process.

• Develop and manage commercial manufacturing strategies and operational plans across various projects.

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

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

• Prepare supporting documentation for global regulatory submissions and offer technical assistance for Health Authority inquiries.

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

• Collaborate with Quality Assurance and Regulatory Affairs to ensure adherence to GxP and global regulatory standards.

• Ensure compliance with budget, schedules, and performance targets.

• Potentially recruit, mentor, and develop staff based on future company needs.

⛳️ Requirements

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

• PhD is strongly preferred.

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

• Proven experience in the development and manufacturing of small molecule dosage forms.

• NDA experience is mandatory.

• Ideally, a minimum of 10 years of industry experience in manufacturing small molecule API in compliance with cGMP regulations.

• Comprehensive understanding of US and EU cGMP requirements, ICH guidelines, and best practices related to drug products and APIs.

• In-depth knowledge of formulation development and drug product manufacturing throughout all phases of drug development, from initial regulatory filings to registration, scale-up, validation, launch, and commercial supply.

• Willingness to travel up to 50%, frequently outside the local area and overnight.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• 401K plan.

• Eligibility to participate in Mineralys incentive plans based on personal and company performance achievements.