We are currently looking for a CMC Leader for one of our client, an international pharmaceutical growing company with great projects, to manage all CMC operations and projects portfolio, working in small and large molecule, in Lausanne or Zurich
Manage all operations for the different CMC development projects, from end to end (early stage to post-registration), including Life cycle management, maintenance and troubleshooting… To build and manage the CMC's project portfolio
Ensure that timeline, deliverables, resources, budgets, etc. are established and followed.
Organize and lead the management of CMC documentation and control documents previously written by your team.
As a Leader, manage a small team working on CMC projects and provide support and training to help them grow.
Scientific Background (MS or PhD) in Chemistry, pharmaceutical or Biology with PMP certification is required
A minimum of 5-10 years’ experience in project and portfolio management for CMC activities (end-to-end management) for pharmaceutical and medical device field is required
Profound knowledge of the regulatory requirements for pharmaceutical products and medical devices (GMP, GCP, ICH...).
Used to deal with budgets (preparation, analysis, follow-up…), dashboard, planning
Strong experience in the compilation of the CMC documentation (CTD/CTA/BLA…).