- Be responsible for the planning, coordination and reporting of CMC projects in the development phase and during the life cycle management of marketed products.
- Collaborating with Procurement to set-up supply agreements and establish development contracts with external partners
- Establishing and maintain effective communication channels to provide accurate information to the Technical Operations Leadership Team, functional line management, Project Team leadership, and R&D functions
- Creation and maintenance of internal program documentation
- Managing CMC project risks including project analyses and elaboration of mitigation actions
- Ensuring coordination with internal and external partners to align efforts with the company strategy to develop, market new chemical and biological products and to maintain and supply the current marketed product portfolio
- Technical degree in Life Science, pharmaceutical technology, chemical engineering, biotechnology, at least Master level
- At least 5 years of experience in Project Management in Life Sciences
- Knowledge of applicable regulatory guidelines
- Experienced in all CMC aspects during late stage development, launch and life cycle management for biological and chemical entities
- Interest to work in a commercial setting with multiple stake holders globally
By joining this company, you will be able to evolve in an environment where the career development is visible, you will be part of passionate QA team, innovative and growing Biotech company.
