CMC Leader

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

Your Responsibilities

  • 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.

Your Profile

  • 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…).
  • Fluent in English ; other language is a plus

For more information, feel free to contact : Noémie Oliva: noliva@axepta.com

Noémie OLIVA

Noémie OLIVA

Team leader & Recruitment Manager Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

CMC Leader

Aug 31, 2021CMC LeaderLausanne Zurich Full Time Permanent Job noliva@axepta.com Life Sciences

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