Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
The CMC (Chemistry, Manufacturing and Controls) Project Manager is responsible for the effective coordination and execution of CMC activities for one or more development projects involving a New Chemical Entity (NCE) or new drug combinations.
Main Responsibilities
Represent the CMC function within the global development team (core team).
Lead the cross-functional CMC sub-team, including subject matter experts in drug substance, drug product, analytical development, quality assurance, clinical supply, and CMC regulatory affairs.
Oversee and coordinate external development and manufacturing partners, including international subcontractors.
Define and implement the CMC development strategy for assigned projects.
Develop and maintain detailed CMC development plans, timelines, and deliverables.
Conduct CMC risk assessments with the internal CMC team and propose mitigation strategies.
Ensure alignment of CMC activities with overall project goals, regulatory requirements, and clinical timelines.
Collaborate closely with internal departments (e.g., regulatory affairs, clinical, commercial, and quality) to ensure seamless project execution.
Monitor CMC project budgets and resource planning.
Contribute to regulatory submissions by providing CMC documentation and expertise.
About You
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
