We are looking for a CMC Leader Late Development!.
The core purpose of the role is to manage the CMC activities according to the integrated project development -, CMC - and clinical plan for various compound development projects.
- As CMC Leader Late Development, you will be responsible for the CMC development strategy and execution thereof for various late development projects.
- Being the CMC project spokesperson for other departments/areas and interact with these.
- Determining the CMC development strategy and development challenges with the CMC team, manage the CMC team.
- Collaboration with the Quality and Compliance department for project related quality topics.
- Collaboration and interaction with the New Product Introduction department and external development partners for commercial development and manufacturing.
- Adherence to existing Policies and Procedures
- Staying abreast of current and new technologies applicable for CMC development and applicable regulations and guidelines
- Represent the CMC team in the Project team and Clinical Development team and align on strategy, planning and activities.
- Ensure the CMC plan and strategy are executed according to plan.
- Provide CMC budget information /update in line with the integrated development plan.
- Ensure CMC source documents for clinical trial applications and NDA/MAA (quality section) are timely available and are properly stored / archived.
- Acting as primary contact/spokesperson for interaction with competent authorities for CMC related topics (questions or meetings).
- Interaction with other CMC team members (Analytical Leader, Drug product Leader, Drug Substance Leader, CMC Dossier writer and Clinical supply Leader) and to build the CMC development plan and ensure execution thereof.
- Ensure the PSF is managed and kept up to date.
- Master degree or PhD in pharmaceutical sciences or bio-engineering or equivalent by experience.
- At least 5 years of relevant experience in a CMC late development role.
- Good understanding and knowledge of CMC Regulatory requirements for late development and commercial stage projects
- Excellent verbal and written English language skills required.
- Team player with strong interpersonal and leadership skills.
- Ability to actively listen and engage in constructive communication with the different team members.
- Strong organisation skills and excellence in planning and supervising projects.
- Hands-on and pragmatic.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’
For more information please contact me at: +31 (0)20 20 44 502 or email@example.com.