Stability & Release Specialist
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a Stability & Release Specialist you will coordinate the release of raw materials and stability testing of products.
- Coordinates 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.
- Coordinates the stability testing of large molecule products according local procedures and agreed timelines.
- Acting as subject matter expert on release and stability processes and has a leading role during the GMP inspections.
- Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience
- Responsible to coordinate all data requests provided by various stakeholders (RA; Health Authority; DPDS etc) and has the accountability to plan, organize, prioritize and execute the data Requests based on the stakeholder requests.
- Leads and drives continuous improvement projects.
- Adhere to compliance best practices, EHSS regulations and lean principles.
- Bachelor's Degree in Life Sciences discipline
- Min. 2 years of experience in a similar role, preferably with large molecules
- Advanced knowledge on lab systems and lab environment, data integrity and data management.
- Knowledge of statistical data analyses.
- Lean/BE experience
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.