Career Opportunities: Associate CMC Specialist (4226) Porto

Career Opportunities: Associate CMC Specialist (4226)
Porto
Porto, Porto District, Portugal

Requisition ID 4226 - Posted - Portugal - Porto

As a key player in the CMC area, your mission is to ensure the successful internalization of manufacturing processes by coordinating
- functional activities between internal teams,

while driving regulatory alignment and process optimization across new and legacy products.

The Impact You’ll Make

1. Planning and follow up of process internalization activities;
2. 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);
3. Open/ evaluate Change Controls (when applicable);
4. Manage, and efficiently follow up, the transdisciplinary interactions related with Legacy Products;
5. Propose and challenge the scope of monthly CMC meetings.

What You’ll Bring

1. Academic degree in relevant discipline;
2. Knowledge of the regulations and procedures in the Pharmaceutical Industry;
3. Know how in task management;
4. Autonomy, proactivity and good organization skills;
5. Fluency in English (spoken and written);
6. Excellent communication skills and ability to enhance partnerships with internal and external stakeholders;
7. Capable of setting priorities and quickly solve problems.

This is a temporary position - 12 months.

Create Your Path@BIAL

“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)