Product Steward I (Biologics Manufacturing)

About the role

Novartis is looking for a Product Steward I (Ekspert tehnologije izdelkov) for its MS&T DS Bioproduction team in Mengeš, Slovenia. You will be the product and process expert throughout the commercial lifecycle of biologic drug substances, owning process knowledge, driving data-based decisions and working with cross-functional teams to ensure robust manufacturing, regulatory compliance and reliable supply. Relocation support is not offered.

Key responsibilities

• Own product and process knowledge and monitor process performance through data trending and statistical analysis
• Provide expert support and oversight of drug substance manufacturing processes
• Create, review and maintain technical, validation and lifecycle management documentation
• Lead investigations, root-cause analyses and corrective and preventive actions (CAPA)
• Assess technical changes and their impact on quality, process performance and compliance
• Collaborate on lifecycle management, regulatory activities and inspection readiness
• Support the introduction of new products, processes and technologies and contribute to regulatory documentation
• Take part in operational excellence and process optimisation initiatives

Required profile

• University degree in biotechnology, pharmacy, chemistry, chemical engineering, pharmaceutical technology or a related natural science field
• At least five years of experience in biologics or pharmaceutical manufacturing
• Good knowledge of bio-pharmaceutical production processes, including upstream and downstream technologies
• Experience with technical documentation, validation activities and lifecycle management
• Knowledge of GMP, quality systems and regulatory guidelines
• Desirable: project leadership experience and experience using statistical tools and data analysis

What we offer

• Permanent employment with a 6-month probation period
• Expected annual base pay of 32,060 to 59,540 EUR
• Annual bonus of 12% of annual pay, holiday allowance and performance award
• Voluntary supplementary pension insurance and accident insurance
• Collective health insurance for specialists and Care Connect mental health support
• Transport, meals and other statutory benefits