Novartis

Overview

In Biologics DS Development Mengeš, Cell Banking, we are looking for a Senior Expert, Technical Development responsible for the strategy and execution of processes for GMP production and testing of cell banks.

About Novartis

Novartis is committed to reimagining medicine together and rewarding the people who make it happen, building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Requirements & Eligibility

• PhD with at least 3 years of relevant experience, or MSc with at least 5 years of relevant experience in pharmaceutical technology, biotechnology, biochemistry, chemical engineering or another relevant natural science field
• Knowledge of general GxP standards and regulatory requirements in manufacturing in a low-bioburden environment
• In-depth understanding of work with cell lines and molecular analytical methods
• Ability to work in and lead cross-functional teams
• Active knowledge of English language

Key Responsibilities

• Plan and lead cell bank manufacturing and testing in accordance with GxP standards; review and approve completed batch records and analytical reports
• Ensure compliance with regulatory requirements (ICH, FDA, EMA)
• Independently plan and coordinate execution, allocate work among technicians and analytics
• Prepare documentation for cell bank manufacturing and testing, including supporting documentation
• Independently manage deviations from Good Manufacturing Practice and manage change control in the GMP environment
• Act as a key manufacturing and testing expert during inspections and audits
• Lead the evaluation, development and implementation of new manufacturing and testing approaches
• Train and mentor colleagues