Cell Bank GMP Process Expert & SME

C028 (FCRS = CH028) Novartis Pharma AG; Basel; Vor Ort; CHF 74.000 - 138.000; Vollzeit

Benefits dieser Stelle

Flexible and hybrid working options

Competitive benefits

Zusammenfassung

Novartis Pharma AG in Basel is seeking a highly skilled Cell Bank Process Specialist to lead the lifecycle of cell banks and ensure GMP-compliant manufacturing. You will act as SME, coordinating with global teams and external stakeholders to maintain regulatory compliance and manufacturing readiness.

The role requires a strong background in Upstream mammalian cell processes, 3+ years on GMP shop floors, and fluency in English and German.

Qualifikationen

• BSc in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Minimum 3-year 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).
• Excellent interpersonal & communication skills.
• Fluent in English and German.

Aufgaben

• Lead the lifecycle management of cell banks, ensuring availability, inventory control, manufacturing, qualification, registration, and compliance with global regulatory requirements.
• Act as the primary technical and regulatory contact for cell bank and manufacturing activities, coordinating with global functions, development teams, manufacturing sites, and external stakeholders.
• Serve as SME for assigned products and processes, providing real-time shop floor support, troubleshooting technical issues, and ensuring rapid implementation of corrective actions.
• Ensure timely and GMP-compliant execution of manufacturing operations, including batch monitoring, batch record review, process validation, changeovers, and maintenance of production documentation.
• Drive training, qualification, and capability development of production teams by designing, delivering, and supporting technical training and qualification programs.
• Lead deviation, complaint, OOS/OOE, CAPA, and root cause investigation activities, ensuring effective resolution and continuous process robustness.

Kenntnisse

Interpersonal skills

Communication skills

English

German

GMP manufacturing

Process support

Ausbildung

BSc in Engineering/Pharmaceutical Science

Jobbeschreibung

Novartis Pharma AG in Basel is seeking a highly skilled Cell Bank Process Specialist to lead the lifecycle of cell banks and ensure GMP-compliant manufacturing. You will act as SME, coordinating with global teams and external stakeholders to maintain regulatory compliance and manufacturing readiness.

The role requires a strong background in Upstream mammalian cell processes, 3+ years on GMP shop floors, and fluency in English and German.