Beschreibung
Job Description:Act as a Subject Matter Expert in BDSS Cell Bank Center (Manage Deviations, Change controls and Batch record review). Support Biotechnology Platform initiatives on Cell Banks management procedures. Drive standardization and harmonization of Cell Banks management processes within Biotechnology Platform, ensuring that improved procedures are in line with the corresponding HSE, GMP- and regulatory compliance standards.
Minimum requirements :
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Desirable MSc. or equivalent experience.
• Fluent German (written & spoken) and English
• Experience in process support role on the shop floor of GMP manufacturing.
• Excellent knowledge of Upstream processes using mammalian cells. Very good understanding of cell bank processes (manufacturing, testing, and storage).
• Proven process understanding (Pharma, GMP, Regulatory aspects)