Associate CMC Specialist

Associate CMC Specialist

Bial

Porto, Portugal

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.

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