Associate Cmc Specialist
1 semana atrás
**Your Mission**
As a key player in the CMC area, your mission is to ensure the successful internalization of manufacturing processes by coordinating cross-functional activities between internal teams,
while driving regulatory alignment and process optimization across new and legacy products.
**The Impact You’ll Make**
- Planning and follow up of process internalization activities;
- CMC liaison with Quality, R&D, Supply & Regulatory (process internalization, follow up on the course of API manufacturing campaigns and downstream quality and regulatory impacts);
- Open/ evaluate Change Controls (when applicable);
- Manage, and efficiently follow up, the transdisciplinary interactions related with Legacy Products;
- Propose and challenge the scope of monthly CMC meetings.
**What You’ll Bring**
- Academic degree in relevant discipline;
- Knowledge of the regulations and procedures in the Pharmaceutical Industry;
- Know how in task management;
- Autonomy, proactivity and good organization skills;
- Fluency in English (spoken and written);
- Excellent communication skills and ability to enhance partnerships with internal and external stakeholders;
- Capable of setting priorities and quickly solve problems.
**This is a temporary position - 12 months.**
“The innovative projects continue to motivate me, and the people as well because they are incredibly passionate about what they do, very curious, and unafraid to face the unknown.”
Miguel Fonseca (Senior Data Scientist, Portugal)
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