Analyst / Coordinator Stability
This biopharmaceutical company is committed to developing first-in-class vaccines for some of the world’s most life-threatening infectious diseases such as Ebola, RSV and HIV.
The Stability Department is responsible for the oversight of stability and release programs of commercial biological products such as Darzalex, Remicade, Stelara, and products in process validation for commercialization such as CNTO4424, GPRC5D, CD3 etc. The services provided by this department also include technical transfer of the NPI’s, data management, release testing of raw materials, biological drug substances and drug products.
In this department, you are responsible for the release and stability coordination, and act as single point of contact for commercial product coordination within quality control.
- You coordinate the release of raw materials, drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines;
- You coordinate the stability testing of large molecule products according local procedures and agreed timelines;
- You are a subject matter expert on release and stability processes and have a leading role during the GMP inspections;
- You join meetings of the quality network organization and partner with customers (e.g. CMOs, manufacturing sites, PQM) to ensure flawless experience;
- You coordinate all data requests provided by various stakeholders (Regulatory Affairs, health authorities, DPDS etc.) and are accountable for planning, organizing, prioritizing and executing the data requests.
- At least a Bachelor's degree;
- 3+ years of work experience in the pharmaceutical environment;
- You combine experience in the lab with coordination experience/skills;
- You have a flexible and proactive personality and are able to define your own work;
- You aren't afraid to stand your ground (for good client management)