Director, Commercial CMC Programs

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Formulate manufacturing and operational strategies for both commercial and late-stage clinical assets.

• Supervise a team of CMC program leaders.

• Guarantee the implementation of CMC strategies by collaborating with internal and external stakeholders.

• Organize and execute CMC activities for Precision Medicine Diagnostics and Therapeutics initiatives.

• Establish global production, supply chain, logistics, and distribution to facilitate clinical-to-commercial advancement.

• Collaborate with contract manufacturers and act as the primary liaison and escalation point for the External Contract Manufacturer network.

• Oversee the manufacturing, quality, and product development from mid-stage clinical trials to commercial manufacturing.

• Administer contracts, budgets, cost-saving initiatives, and capacity management.

• Maintain the ECM strategy in partnership with Manufacturing Operations, Biologics, Radiochemistry, CMC Programs, Supply Chain, and Procurement.

• Coordinate both internal and external communications to resolve business challenges.

• Drive the development and performance management of Commercial CMC Program Leads.

• Conduct supplier performance business reviews.

• Develop and populate ECM metrics scorecards and dashboards.

• Oversee commercial manufacturing budgets and initiatives for continuous improvement.

⛳️ Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, Business, or a related field.

• Over 10 years of combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality.

• Proven experience in managing cross-functional teams, external partners, and CDMOs is essential.

• Experience in overseeing cross-functional teams and International Contract Manufacturing Organizations is necessary.

• Willingness to travel approximately 30% of the time, both domestically and internationally.

• Direct experience with Sterile Injectable Filling and Lyophilization of Drug Products/Substances for both pre-commercial and commercial products is preferred.

• Direct experience in Secondary Packaging of Parenteral drugs is preferred.

• Direct experience with complex formulations of bulk drug substances and biologic drug substance manufacturing is preferred.

• Excellent communication, collaboration, adaptability, ethical behavior, and a commitment to continuous learning are required.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and professional development.

• Competitive salary packages.