CMC Development Project Leader

  • Basel
  • Posted: Aug 23, 2021

We are currently looking for a CMC Development Project Leader to manage all CMC operations and projects portfolio, working in cross-functional team.

Responsabilities :

  • 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 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 : Morgane CAYUELA: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

CMC Development Project Leader

Aug 23, 2021CMC Development Project LeaderBasel Permanent Job mc@axepta.com Life Sciences

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