Director, Manufacturing Operations

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

📋 Description

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

• Collaborate with leadership from Regional Operations, Supply Chain, Program management, and Directors of CMC Programs.

• Ensure effective leadership, implementation, and successful delivery of process development and enhancements.

• Guarantee adherence to contracts, regulatory standards, and commercial feasibility.

• Plan global production, logistics, supply chain, and distribution activities.

• Supervise subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging.

• Partner with contract manufacturers to ensure that quality, deliveries, and costs meet or surpass expectations.

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

• Develop strategies with CDMOs for cost reduction, supply redundancy, and process optimization.

• Address complex technical challenges and assist with quality investigations and non-conformances.

• Lead and manage manufacturing engineers, including providing coaching and performance evaluations.

• Act as the technical lead for supplier and contracting organization business reviews.

• Oversee technical transfers and process validation at both internal and external CDMOs.

⛳️ Requirements

• BA or BS degree in Engineering, Biology, Chemistry, or a related field.

• Over 10 years of combined experience in late-stage clinical to commercial cGMP Manufacturing, Engineering, Contract Manufacturing, and/or Quality.

• More than 3 years of prior management experience.

• Direct experience in Sterile Injectable Filling and Lyophilization of Drug Products/Substances for both clinical and commercial products.

• Preferred experience in the Secondary Packaging of Parenteral drugs.

• Preferred experience in complex formulations of bulk drug substances and biologic drug substance manufacturing.

• Experience collaborating with International Contract Manufacturing Organizations.

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

• Strong capabilities in communication, collaboration, adaptability, and ethical practices.

• Dedication to continuous learning and professional growth.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work options.