Analyst Stability, NPI & New Technology
They are a global biopharmaceutical company, that works hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time — from heart disease, diabetes, and psoriasis to Alzheimer’s, HIV, and cancer.
As a part of the lab situated at the site in Leiden, Stability, NPI & New technology group 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 team you are responsible for the release and stability coordination and act as single point of contact for commercial product coordination within Leiden QC.
- 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;
- Coordinate the stability testing of large molecule products according to 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, JSC manufacturing sites, PQM) to ensure a flawless experience;
- You are responsible for coordinating all Data requests provided by various stakeholders (RA; Health Authority; DPDS etc) and you have the accountability to plan, organize, prioritize and execute the Data Requests based on the stakeholder requests.
- You have affinity and motivation to lean the process continuously and to apply Business Excellence and Faster Forward tools.
- Education minimum relevant HBO diploma
- At least 3 years of work experience in the pharmaceutical environment
- Must have 1-2 years of Project Management experience
- Excellent interpersonal and organizational skills
- Knowledge and Affinity with Business Excellence tools and Faster Forward mindset
- Proficient in the use of lab systems & lab environment, particularly around data integrity and data management (eg. eLIMS)