Commercial Operations Director – Manufacturing

📋 Description

• Oversee the execution of the TLX101Px commercial distribution strategy, which encompasses vendor contracting, process development, and the coordination of logistics and supply chain operations to facilitate the commercial launch.

• Build and sustain robust partnerships with contract manufacturers, distributors, and logistics service providers.

• Create and maintain operational reporting tools, dashboards, and analytics that support the commercial team effectively.

• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure adherence to compliance standards.

• Work in close cooperation with Clinical, Manufacturing, Regulatory, and Commercial teams to synchronize operational processes with overarching business objectives.

• Identify and implement opportunities to improve workflows and processes, enhance vendor performance, and maximize cost efficiency within the supply chain.

⛳️ Requirements

• Education: PharmD, M.S. or B.S. degree in chemistry, biology, or a related field; an advanced degree is preferred.

• At least 5-7 years of leadership experience in the development, manufacturing, and commercialization of PET biomarkers or radiopharmaceuticals utilized in commercial operations.

• Comprehensive knowledge of GMP and commercial product development requirements, including compliance with 21 CFR 212 and USP standards.

• Strong grasp of the processes and considerations specific to short half-life radiopharmaceutical products.

• Demonstrated experience in managing external partners, CMOs, and distribution vendors.

• Willingness to travel as necessary to fulfill job responsibilities.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development

• Health insurance

• Retirement plans