Director, Commercial CMC Programs

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

📋 Description

• Formulate manufacturing and operational strategies for commercial and late-stage clinical assets in partnership with Regional Operations leadership, Supply Chain, Program leadership, and the Director of Manufacturing Operations.

• Supervise a team of CMC program leads.

• Ensure successful implementation of CMC strategies through effective collaboration with both internal and external stakeholders.

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

• Establish and reinforce global production, supply chain, logistics, and distribution to support late-phase clinical development and commercial manufacturing.

• Collaborate with contract manufacturers, acting as a liaison and escalation contact between Telix and the External Contract Manufacturer network.

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

• Manage contracts, budgets, cost-saving initiatives, capacity management, and continuous improvement efforts.

• Maintain the ECM strategy and establish, own, and oversee ECM operating mechanisms.

• Facilitate communication across internal and external teams and resolve issues effectively.

• Lead, mentor, coach, and evaluate the performance of Commercial CMC Program Leads.

• Conduct performance business reviews with suppliers and contracting organizations.

• Create and maintain ECM metrics scorecards and dashboards.

⛳️ Requirements

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

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

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

• Experience leading cross-functional teams and International Contract Manufacturing Organizations is important.

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

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

• Experience in Secondary Packaging of Parenteral drugs is a plus.

• Background in complex formulations of bulk drug substances and biologic drug substance manufacturing is advantageous.

• A strong commitment to excellence.

• Results-driven mindset.

• Creativity and innovation.

• Excellent communication abilities.

• Strong collaboration skills.

• Resilience in the face of challenges.

• An inclusive approach.

• Adaptability to changing environments.

• Ethical conduct.

• Dedication to continuous learning and professional growth.

🏝️ Benefits

• Competitive salary packages.

• Annual performance-based bonuses.

• Equity-based incentive programs.

• Generous vacation time.

• Paid wellness days.

• Support for learning and development initiatives.

• Flexible hybrid and remote work options.